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100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO , Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI ® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 ( Abstract #493 ) and MajesTEC-4 ( Abstract #494 ) studies establish the potential of TECVAYLI ® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting. 1,2 Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI ® in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO ® , bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study. 1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10 -5 ) and maintained through cycle 6. 1 "These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we're developing, including our bispecific antibodies in new combinations, and we're committed to exploring the full potential of our therapies to improve outcomes for patients." The safety profiles were manageable and consistent with individual safety profiles. 1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients. 1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). 1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent). 1 "There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting," said Marc S. Raab , M.D., Heidelberg University Hospital, Germany .* "These data reinforce the potential of TECVAYLI when used in earlier lines and show that TECVAYLI can be leveraged to optimize existing standard regimens in combination." Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI ® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT). 2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT. 2 Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. 2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI ® dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent). 2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent). 2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. 2 Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling. About MajesTEC-5 Study MajesTEC-5 ( NCT05695508 ) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with newly diagnosed transplant eligible multiple myeloma. 3 About MajesTEC-4 Study MajesTEC-4 ( NCT05243797 ) is an ongoing, multicenter, randomized, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation. 4 About MajesTEC-7 Study MajesTEC-7 ( NCT05552222 ) is a Phase 3 randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. 5 About TECVAYLI ® TECVAYLI ® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. 6 The European Commission (EC) granted TECVAYLI ® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023 , the EC granted the approval of a Type II variation application for TECVAYLI ® , providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI ® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024 , the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI ® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. For more information, visit www.TECVAYLI.com . About DARZALEX FASPRO ® and DARZALEX ® DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO ® is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE ® drug delivery technology. DARZALEX ® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX ® -based regimens have been used in the treatment of more than 585,000 patients worldwide and more than 239,000 patients in the U.S. alone. In August 2012 , Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit https://www.darzalexhcp.com. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors. 8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease. 9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease. 10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent. 11 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections. 12,13 TECVAYLI ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL- ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI ® . Initiate treatment with TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life- threatening reactions, can occur in patients receiving TECVAYLI ® . Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI ® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI ® is available only through a restricted program called the TECVAYLI ® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). INDICATION AND USAGE TECVAYLI ® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI ® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI ® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI ® . The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI ® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI ® based on severity. TECVAYLI ® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI ® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI ® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI ® . In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI ® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI ® . The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI ® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI ® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI ® is available only through a restricted program under a REMS. TECVAYLI ® and TALVEY ® REMS - TECVAYLI ® is available only through a restricted program under a REMS called the TECVAYLI ® and TALVEY ® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI ® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Infections - TECVAYLI ® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI ® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI ® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI ® based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI ® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI ® and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI ® . DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO ® . Systemic Reactions In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO ® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO ® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO ® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO ® . Local Reactions In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO ® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO ® until recovery of platelets. Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX FASPRO ® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX FASPRO ® . Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO ® -treated patients with IgG kappa myeloma protein. ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to see the full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TECVAYLI ® (teclistamab-cqyv ) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. * Marc S. Raab , M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Raab, Marc, S., et al, 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 2 Zamagni, Elena, et al., 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 3 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). https://clinicaltrials.gov/study/NCT05695508 . Accessed November 2024 . 4 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). https://clinicaltrials.gov/study/NCT05243797 . Accessed November 2024 . 5 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). https://classic.clinicaltrials.gov/ct2/show/NCT05552222 . Accessed November 2024 . 6 U.S. FDA Approves TECVAYLI ® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . Accessed November 2024 . 7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq . Accessed November 2024 . 9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma . Accessed November 2024 . 10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women . Accessed November 2024 . 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/ . Accessed November 2024 . 12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed November 2024 . 13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html . Accessed November 2024 . Media contacts: Sarah Freeman sfreem21@its.jnj.com Christie Corbett ccorbet6@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-demonstrates-potential-as-frontline-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-302325575.html SOURCE Johnson & JohnsonFacebook Twitter WhatsApp SMS Email Print Copy article link Save Players must be assigned female at birth or have transitioned to female before going through male puberty to compete in LPGA tournaments or the eight USGA championships for females under new gender policies published Wednesday. The policies, which begin in 2025, follow more than a year of study involving medicine, science, sport physiology and gender policy law. The updated policies would rule out eligibility for Hailey Davidson, who missed qualifying for the U.S. Women’s Open this year by one shot and came up short in LPGA Q-school. Davidson, who turned 32 on Tuesday, began hormone treatments when she was in her early 20s in 2015 and in 2021 underwent gender-affirming surgery, which was required under the LPGA’s previous gender policy. She had won this year on a Florida mini-tour called NXXT Golf until the circuit announced in March that players had to be assigned female at birth. Hammonton police sergeant accused of failing drug test, stealing drugs from evidence room Mays Landing man charged in hit-and-run that injured man, killed dog in Absecon $680,000 Atlantic City charter bus purchase mostly covered by state, Small says Pleasantville man accused of murdering girlfriend Mainland Regional falls to Old Tappan in state final 4 Bridgeton men indicted in alleged sex trafficking ring Everything you need to know about Mainland Regional's state title game Wonderland developer to pitch vision again Wednesday at Ocean City Tabernacle Atlantic City mayor waives first appearance on witness tampering charge Northfield Councilman Leeds resigns, citing concerns over Mayor Chau's criminal charges Some Atlantic City casino workers call on union boss to resign for opposing a smoking ban Mays Landing man busted for meth Northfield intersection to become four-way stop Biden pardons his son Hunter despite previous pledges not to Longport administrator and former police chief Scott Porter dies “Can’t say I didn’t see this coming,” Davidson wrote Wednesday on an Instagram story. “Banned from the Epson and the LPGA. All the silence and people wanting to stay ‘neutral’ thanks for absolutely nothing. This happened because of all your silence.” LPGA commissioner Mollie Marcoux Samaan, who is resigning in January, said the new gender policy “is reflective of an extensive, science-based and inclusive approach.” By making it to the second stage of Q-school, Davidson would have had very limited status on the Epson Tour, the pathway to the LPGA. The LPGA and USGA say their policies were geared toward being inclusive of gender identities and expression while striving for equity in competition. The LPGA said its working group of experts advised that the effects of male puberty allowed for competitive advantages in golf compared with players who had not gone through puberty. “Our policy is reflective of an extensive, science-based and inclusive approach,” said LPGA Commissioner Mollie Marcoux Samaan, who announced Monday that she is resigning in January. “The policy represents our continued commitment to ensuring that all feel welcome within our organization, while preserving the fairness and competitive equity of our elite competitions.” Mike Whan, the former LPGA commissioner and now CEO of the USGA, said it developed the updated policy independently and later discovered it was similar to those used by swimming, track and field, and other sports. United States Golf Association CEO Mike Whan said the new policy will prevent anyone from having “a competitive advantage based on their gender.” “It starts with competitive fairness as the North star,” Whan said in a telephone interview. “We tried not to get into politics, or state by state or any of that stuff. We just simply said, ‘Where would somebody — at least medically today — where do we believe somebody would have a competitive advantage in the field?’ And we needed to draw a line. “We needed to be able to walk into any women’s event and say with confidence that nobody here has a competitive advantage based on their gender. And this policy delivers that.” The “Competitive Fairness Gender Policy” for the USGA takes effect for the 2025 championship season that starts with the U.S. Women’s Amateur Four-Ball on May 10-14. Qualifying began late this year, though there were no transgender players who took part. “Will that change in the years to come as medicine changes? Probably,” Whan said. “But I think today this stacks up.” The LPGA “Gender Policy for Competition Eligibility” would apply to the LPGA Tour, Epson Tour, Ladies European Tour and qualifying for the tours. Players assigned male at birth must prove they have not experienced any part of puberty beyond the first stage or after age 12, whichever comes first, and then meet limitation standards for testosterone levels. The LPGA begins its 75th season on Jan. 30 with the Tournament of Champions in Orlando, Florida. Buffalo Bills quarterback Josh Allen, foreground right, dives toward the end zone to score past San Francisco 49ers defensive end Robert Beal Jr. (51) and linebacker Dee Winters during the second half of an NFL football game in Orchard Park, N.Y., Sunday, Dec. 1, 2024. (AP Photo/Adrian Kraus) South Carolina guard Maddy McDaniel (1) drives to the basket against UCLA forward Janiah Barker (0) and center Lauren Betts (51) during the first half of an NCAA college basketball game, Sunday, Nov. 24, 2024, in Los Angeles. (AP Photo/Eric Thayer) Mari Fukada of Japan falls as she competes in the women's Snowboard Big Air qualifying round during the FIS Snowboard & Freeski World Cup 2024 at the Shougang Park in Beijing, Saturday, Nov. 30, 2024. (AP Photo/Andy Wong) LSU punter Peyton Todd (38) kneels in prayer before an NCAA college football game against Oklahoma in Baton Rouge, La., Saturday, Nov. 30, 2024. LSU won 37-17. (AP Photo/Gerald Herbert) South Africa's captain Temba Bavuma misses a catch during the fourth day of the first Test cricket match between South Africa and Sri Lanka, at Kingsmead stadium in Durban, South Africa, Saturday, Nov. 30, 2024. (AP Photo/Themba Hadebe) Philadelphia Eagles running back Saquon Barkley, left, is hit by Baltimore Ravens cornerback Marlon Humphrey, center, as Eagles wide receiver Parris Campbell (80) looks on during a touchdown run by Barkley in the second half of an NFL football game, Sunday, Dec. 1, 2024, in Baltimore. (AP Photo/Stephanie Scarbrough) Los Angeles Kings left wing Warren Foegele, left, trips San Jose Sharks center Macklin Celebrini, center, during the third period of an NHL hockey game Monday, Nov. 25, 2024, in San Jose, Calif. (AP Photo/Godofredo A. Vásquez) Olympiacos' Francisco Ortega, right, challenges for the ball with FCSB's David Miculescu during the Europa League league phase soccer match between FCSB and Olympiacos at the National Arena stadium, in Bucharest, Romania, Thursday, Nov. 28, 2024. (AP Photo/Andreea Alexandru) Brazil's Botafogo soccer fans react during the Copa Libertadores title match against Atletico Mineiro in Argentina, during a watch party at Nilton Santos Stadium, in Rio de Janeiro, Saturday, Nov. 30, 2024. (AP Photo/Bruna Prado) Seattle Kraken fans react after a goal by center Matty Beniers against the San Jose Sharks was disallowed due to goaltender interference during the third period of an NHL hockey game Saturday, Nov. 30, 2024, in Seattle. The Sharks won 4-2. (AP Photo/Lindsey Wasson) New York Islanders left wing Anders Lee (27), center, fight for the puck with Boston Bruins defensemen Parker Wotherspoon (29), left, and Brandon Carlo (25), right during the second period of an NHL hockey game, Wednesday, Nov. 27, 2024, in Elmont, N.Y. (AP Photo/Julia Demaree Nikhinson) Jiyai Shin of Korea watches her shot on the 10th hole during the final round of the Australian Open golf championship at the Kingston Heath Golf Club in Melbourne, Australia, Sunday, Dec. 1, 2024. (AP Photo/Asanka Brendon Ratnayake) Mathilde Gremaud of Switzerland competes in the women's Freeski Big Air qualifying round during the FIS Snowboard & Freeski World Cup 2024 at the Shougang Park in Beijing, Friday, Nov. 29, 2024. (AP Photo/Andy Wong) Lara Gut-Behrami, of Switzerland, competes during a women's World Cup giant slalom skiing race, Saturday, Nov. 30, 2024, in Killington, Vt. (AP Photo/Robert F. Bukaty) New York Islanders goaltender Ilya Sorokin cools off during first period of an NHL hockey game against the Boston Bruins, Wednesday, Nov. 27, 2024, in Elmont, N.Y. (AP Photo/Julia Demaree Nikhinson) Brazil's Amanda Gutierres, second right, is congratulated by teammate Yasmin, right, after scoring her team's first goal during a soccer international between Brazil and Australia in Brisbane, Australia, Thursday, Nov. 28, 2024. (AP Photo/Pat Hoelscher) Las Vegas Raiders tight end Brock Bowers (89) tries to leap over Kansas City Chiefs cornerback Joshua Williams (2) during the first half of an NFL football game in Kansas City, Mo., Friday, Nov. 29, 2024. (AP Photo/Ed Zurga) Luiz Henrique of Brazil's Botafogo, right. is fouled by goalkeeper Everson of Brazil's Atletico Mineiro inside the penalty area during a Copa Libertadores final soccer match at Monumental stadium in Buenos Aires, Argentina, Saturday, Nov. 30, 2024. (AP Photo/Natacha Pisarenko) Gold medalists Team Netherlands competes in the Team Sprint Women race of the ISU World Cup Speed Skating Beijing 2024 held at the National Speed Skating Oval in Beijing, Sunday, Dec. 1, 2024. (AP Photo/Ng Han Guan) Minnesota Vikings running back Aaron Jones (33) reaches for an incomplete pass ahead of Arizona Cardinals linebacker Mack Wilson Sr. (2) during the second half of an NFL football game Sunday, Dec. 1, 2024, in Minneapolis. (AP Photo/Abbie Parr) Melanie Meillard, center, of Switzerland, competes during the second run in a women's World Cup slalom skiing race, Sunday, Dec. 1, 2024, in Killington, Vt. (AP Photo/Robert F. Bukaty) Houston Rockets guard Jalen Green goes up for a dunk during the second half of an Emirates NBA cup basketball game against the Minnesota Timberwolves, Tuesday, Nov. 26, 2024, in Minneapolis. (AP Photo/Abbie Parr) England's Alessia Russo, left, and United States' Naomi Girma challenge for the ball during the International friendly women soccer match between England and United States at Wembley stadium in London, Saturday, Nov. 30, 2024. 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Have you been drinking more than usual? A new blood test could soon reveal whether your alcohol consumption is harming your liver. Researchers report that a blood-borne byproduct of alcohol called phosphatidyl ethanol (PEth) offers a reliable way to assess liver scarring caused by excessive drinking. This innovative method, published in the American Journal of Gastroenterology, has the potential to revolutionize how doctors diagnose and monitor alcohol-related liver damage. PEth testing provides a more accurate picture of alcohol-related harm compared to relying on self-reported drinking habits. According to Judy Hahn, senior researcher and professor at the University of California, San Francisco (UCSF), this approach is akin to how other health risks are measured: “We don’t ask someone how much fatty food they eat; we measure their cholesterol. Similarly, we weigh people rather than asking how much they think they weigh,” Hahn explained in a UCSF news release. How the Test Works? When the body processes alcohol, it produces PEth, a compound that correlates directly with alcohol consumption. Previous studies have confirmed that blood concentrations of PEth accurately reflect the quantity of alcohol consumed, making it a promising biomarker for liver damage. This test could enable healthcare professionals to better understand a patient's drinking patterns and offer tailored advice to prevent long-term complications. The Scope of the Study Researchers pooled data from 12 studies conducted across the United States, Russia, Uganda, and South Africa, analyzing over 4,600 participants. These studies included PEth testing, self-reported alcohol use, and liver damage measurements. The findings revealed that elevated PEth levels strongly correlated with liver damage scores. In contrast, self-reports of drinking habits showed weaker associations with liver scarring, likely due to underreporting or memory lapses among participants. “This is the largest study yet to examine the relationship between PEth and liver damage,” researchers noted. It’s also the first to compare the effectiveness of PEth testing against self-reports in assessing the risk of liver scarring. The results underline the importance of integrating PEth tests into routine blood work. Why It Matters Heavy drinking is a widespread issue in the United States, with about 24 per cent of adults binge drinking and over 6 per cent classified as heavy drinkers, according to the U.S. Centers for Disease Control and Prevention. Alcohol-related liver disease is a growing public health concern, especially as drinking levels surged during the COVID-19 pandemic. Liver scarring, also known as fibrosis, can be slowed or even reversed by reducing alcohol intake and adopting a healthy diet low in sugar, salt, and fat. However, early detection is crucial to prevent the condition from progressing to more severe stages like cirrhosis or liver failure. The study's lead researcher, Pamela Murnane, an assistant professor of epidemiology and biostatistics at UCSF, emphasized the need for routine PEth testing: “To prevent and manage liver fibrosis, we need to know how much a person is drinking. Self-reports simply don’t provide an accurate grasp of that.” Incorporating PEth testing into standard blood panels could help identify at-risk individuals earlier, allowing for timely interventions to protect liver health. As researchers continue to explore this technology, it holds promise for improving how alcohol-related liver disease is diagnosed and treated, ultimately saving lives. Get Latest News Live on Times Now along with Breaking News and Top Headlines from Health and around the world.
Meta is preparing for a groundbreaking infrastructure project: a 40,000+ kilometer subsea fiber-optic cable encircling the globe. The initiative, expected to cost over $10 billion, marks the first time Meta will own and operate a subsea cable exclusively. Sources close to TechCrunch confirmed the plans, which aim to secure seamless data flow for its platforms like Facebook, Instagram, and WhatsApp. A strategic step for Meta According to the report, the plan begins with a $2 billion budget, but as it scales, the cost could exceed $10 billion. The cable will follow a “W” route, connecting the US east coast to India via South Africa and returning to the US west coast via Australia. The route "avoids areas of geopolitical tension,” a source close to Meta revealed, the report said, referring to recent incidents where subsea cables were damaged by conflict, such as in the Red Sea and the Baltic Sea. India: A key landing point The technology media company highlighted India’s pivotal role in the project. “India could become the training capital of the world,” the source was quoted as saying, citing Meta’s potential plans to build AI training facilities and data centers in the country. India is Meta ’s largest market, with more than 375 million Facebook users, 363 million Instagram users, and 536 million WhatsApp users. The country’s enthusiasm for emerging features like AI tools, combined with a growing data center market, underscores its importance in Meta’s strategy. Broader implications The project reflects a shift in the tech industry, with companies like Meta and Google increasingly investing in private subsea cables to control their data infrastructure. "Tech companies want direct ownership of the pipes needed to deliver content, advertising and more to users around the world," the source said as per the report. Beyond business advantages, geopolitical considerations are also driving the move, the report noted, saying recent attacks and damages to submarine cables have highlighted vulnerabilities in traditional routes, and Meta ’s cable seeks to mitigate these risks while ensuring uninterrupted service to its platforms. Future outlook Although the project is in its early stages, as per the sources cited in the report, Meta will announce details in early 2025. However, challenges loom, including limited availability of manufacturers which are already engaged with other major clients. " AI is part of Meta’s long-term infrastructure roadmap, .... it’s too soon to say whether AI is part of the equation for Meta in this project, describing it as part of the “long tail” of considerations and possibilities," the source was quoted as saying. Meta declined to comment on the project, the report added. However, as the tech giant aims to expand its global reach and cement its infrastructure dominance, this subsea cable could become a cornerstone of its future operations.Don't ignore birth rate dip
By William Lambers The poem, “ ‘ Twas the Night Before Christmas” reads, “The stockings were hung by the chimney with care, In hopes that St. Nicholas soon would be there.” It was the real life St. Nicholas, a 4th century bishop known for his secret gift giving, who inspired the poem and the creation of the “Santa Claus” we know today. But if we want to be true to the real Santa, St. Nicholas, we should give food to the world’s starving people this holiday. For St. Nicholas was known for his work in feeding the hungry. It was St. Nicholas who provided food to the poor during times of famine. Legend has it that St. Nicholas was able to convince others to share food to help those in hunger. The lesson was there is enough food and wealth in the world to feed everyone. Sharing is the true Christmas spirit. With food banks seeing high demand at home and unprecedented hunger emergencies worldwide, the best Christmas gift we could give is food to those in desperate need. The starving child in a refugee camp in the D. R. Congo wants a basket of food more than anything right now. Families in war-torn Gaza, Sudan, Yemen and Syria are desperate for food amid horrible conflicts. But yet there is not enough funding to reach all those suffering in hunger. For the coming year the UN World Food Program (WFP) is appealing for “$16.9 billion to address global food needs and the alarming gap between needs and resources.” That figure is what the world spends drinking coffee for two weeks according to WFP. There are mothers in Sudan, Madagascar, D.R. Congo, and other countries who want a box of Plumpy’Nut this holiday because this enriched food will save their child’s life. There is a major shortage of life-saving food for infants right now. UNICEF, the UN Children’s agency, recently issued an appeal for $165 million because supplies of Ready-to-use-Therapeutic-Food (RUTF) to treat infant malnutrition are running low in 12 nations. These alarming shortages are a disaster as small children will suffer lasting physical and mental damage from malnutrition, or death. Mali, Nigeria, Niger, Chad, Cameroon, Pakistan, Sudan, Madagascar, South Sudan, Kenya, the Democratic Republic of Congo and Uganda are all at risk of running out of food to treat infant malnutrition. The charity Mary’s Meals gives school lunches to children in some of the most impoverished countries in the world. These school lunches are a precious gift to children, giving them life and hope for the future. “Through our collaborative school feeding programs in 17 countries, we see first-hand the hope these initiatives bring to families and communities. Even in the direst circumstances, when children are nourished and able to attend school, these programs provide a sense of stability and hope that with an education, there’s an opportunity for a better future,” said Mary’s Meals USA Executive Director Terry Bonet. What an amazing Christmas it would be if everyone who is facing starvation got life-saving food. That would be what St. Nicholas would do, giving gifts of food to the hungry. You can send a donation to charities like WFP, UNICEF, Mary’s Meals, Save the Children, Catholic Relief Services, Mercy Corps, CARE, Edesia and many others. You could even make the donation in someone’s name to honor them this holiday season. You could leave them a card so they know that the gift of food is on the way to the starving children. That would be in the spirit of St. Nicholas, a Happy Christmas with Food for all, and to all peace and a good night. William Lambers is an author who partnered with the UN World Food Program on the book Ending World Hunger.Cardi B's staggering monthly spending habits revealed after rapper is accused of going broke Cardi, 32, was trolled after taking an endorsement deal with Shein She responded by sharing receipts to prove just how wealthy she is READ MORE: Cardi B reveals her natural hair By J. PETERSON FOR DAILYMAIL.COM Published: 17:48 EST, 4 December 2024 | Updated: 17:59 EST, 4 December 2024 e-mail 55 shares 12 View comments Cardi B has exposed her own lavish spending habits after fans questioned her finances. The rapper, 32, was trolled after she partnered with affordable fast fashion brand Shein for a sponsored social media deal, leading some fans to wonder if she was still making a sizable income from her music career. 'Girl, you wear Hermes and Chanel , not Shein,' commented one, while another wrote, 'This is so embarrassing, Shein promo.' Furious at the speculation, Cardi took to social media to rant about her bank balance. Not only did she brag about spending '$3 million a month,' she also posted a text message exchange that showed that she'd turned down $65 million to go on tour. 'People are saying I'm surviving off Shein deals and brand deals,' she said on X Spaces. Cardi B has exposed her own lavish spending habits after fans questioned her finances 'I want to let y'all know I could wake up tomorrow, sign a contract, and have half of $65 million - or half of $70 million - in my account.' According to the details of the tour deal, the rapper could earn $1.1 million per tour date, $1.5 million for festival shows, and $65 million to go on tour. However, she turned down the offer in the hope that she could earn even more if she waited to time the tour with her long-awaited sophomore album, which is due out next year. 'I'm not taking tour deals until I announce my album because once I do, I know those offers will go up. You have to move smart. You can't act hungry when you're not,' she said. Cardi also posted receipts to show off some of her most expensive purchases, which included dropping $200,000 on bling from bespoke jeweler Eliantte & Co. She spent another $120,000 on Benny the Jeweler, who is known for working with famous rappers, and then $65,000 from luxury resale website Adore the Couture. Cardi's status in the music industry has come into question recently due to the constant delay of her sophomore album . The disc has repeatedly been delayed since 2022, and is now currently due out in 2025. Not only did she brag about spending '$3 million a month', she also posted a text message exchange that showed that she'd turned down $65 million to go on tour Cardi also shared receipts to show that she was spending six figures at various jewelers Her last solo single 'Enough (Miami)' reached the top 10 on the Hot 100 but quickly plunged down the charts. In 2023, she attempted to recreate the success of her smash hit 'WAP' by reteaming with Megan Thee Stallion for the collaboration Bongos , but the song missed the top 10. Cardi's last hit single as a solo artist was 'Up,' which hit No. 1 on the Hot 100 in 2021. Despite slipping on the charts, Cardi is still a hot commodity when it comes to lucrative endorsement deals. The Bronx-born beauty has worked with McDonald's, Marc Jacobs, and Nyx Cosmetics over the last 18 months. She also has her own line of alcohol-infused whipped cream called Whipshots. In a post to X back in April, Cardi bragged that she earns up to $5 million per deal these days. 'Right now I get brand deals for over $5 million for a campaign... I got social media famous in 2014... my first brand deal from Fashion Nova was in 2016 and $200 a post,' she posted. 'You could reach any height no matter how ghetto or where you come from.' Chanel Cardi B Share or comment on this article: Cardi B's staggering monthly spending habits revealed after rapper is accused of going broke e-mail 55 shares Add comment