J&J(JNJ) Prnewswire·2024-07-02 11:30Core Insights - CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for treating multiple myeloma patients who have had at least one prior line of therapy [1] - Johnson & Johnson announced positive results from the Phase 3 CARTITUDE-4 study, showing significant improvement in overall survival for patients treated with CARVYKTI® compared to standard therapies [1][2] - The CARTITUDE-4 study is the first randomized Phase 3 trial evaluating CARVYKTI® against standard care treatments for relapsed or lenalidomide-refractory multiple myeloma [3] Company Overview - Johnson & Johnson is focused on innovative medicine and aims to improve outcomes for patients with multiple myeloma through differentiated therapies [2][37] - The company has a collaboration with Legend Biotech USA, Inc. for the development and commercialization of CARVYKTI® [5] Product Information - CARVYKTI® (ciltacabtagene autoleucel) received FDA approval in February 2022 and was later approved for a broader indication in April 2024 [4] - The therapy is a genetically modified autologous T-cell immunotherapy targeting BCMA, which is primarily expressed on malignant multiple myeloma B-lineage cells [5] - The primary endpoint of the CARTITUDE-4 study is progression-free survival, with secondary endpoints including overall survival and overall response rate [3] Market Context - Multiple myeloma is the third most common blood cancer globally, with over 35,000 new diagnoses expected in the U.S. in 2024 [6][7] - The disease remains incurable, highlighting the need for effective treatment options like CARVYKTI® [6][7] Clinical Data - The CARTITUDE-4 study demonstrated a statistically significant improvement in overall survival for CARVYKTI® compared to standard therapies [1][2] - Safety data from the study were consistent with the approved label, indicating manageable adverse effects [1][2] Regulatory Developments - Updated results from the CARTITUDE-4 study will be presented at medical meetings and submitted to regulatory authorities worldwide [2] - CARVYKTI® has received approvals from both the FDA and the European Medicines Agency for specific patient populations [4]