11-0 Unanimous Vote! FDA ODAC Recommends Carvykti CAR-T for Treatment of Relapsed or Refractory Multiple Myeloma in Earlier Lines of Therapy
11-0 Unanimous Vote! FDA ODAC Recommends Carvykti CAR-T for Treatment of Relapsed or Refractory Multiple Myeloma in Earlier Lines of Therapy
Based on the results of the Phase 3 CARTITUDE-4 study, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-0 in favor of a positive risk-benefit assessment for Carvykti®.
On March 15, 2024, Legend Biotech (NASDAQ: LEGN) announced from Somerset, New Jersey, that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (including a proteasome inhibitor and an immunomodulatory agent) and are refractory to lenalidomide. This positive recommendation was made after the committee evaluated the efficacy and safety data from the Phase 3 CARTITUDE-4 study. The committee unanimously voted in favor of Carvykti® (11-0), determining that the risk-benefit assessment for cilta-cel in the proposed indication was favorable. The supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2024.
Dr. Ying Huang
Chief Executive Officer of Legend Biotech
“The advisory committee’s positive recommendation for Carvykti® moves us one step closer to helping more patients overcome relapsed and refractory multiple myeloma. We are committed to improving the lives of multiple myeloma patients, and we are excited to potentially offer this innovative therapy earlier in their treatment journey.”
The advisory committee reviewed the results from CARTITUDE-4 (NCT04181827), the first randomized Phase 3 study designed to evaluate the efficacy and safety of Carvykti® compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy.
The results from the Phase 3 CARTITUDE-4 study were first presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, and these results also supported the recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Carvykti® in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy (including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD)), and have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
The Oncologic Drugs Advisory Committee (ODAC) is convened by the U.S. FDA to review and evaluate the safety and efficacy data of human drug products intended for the treatment of cancer. The committee provides non-binding recommendations based on its evaluation; the FDA makes the final decision regarding drug approval.
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