Legend Biotech Corporation (NASDAQ: LEGN) has announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA. The sBLA aims to expand the label for Carvykti (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Supporting Data from CARTITUDE-4 Study
The filing is supported by data from the CARTITUDE-4 study (NCT04181827), the first international, randomized, open-label Phase III study evaluating the efficacy and safety of cilta-cel versus standard of care (SOC) regimens in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The SOC in the protocol included pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, and pomalidomide and dexamethasone (DPd). In January 2023, Legend announced that the CARTITUDE-4 study met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the first pre-specified interim analysis. As a result, the Independent Data Monitoring Committee recommended unblinding the study.
Global Partnership and Regulatory Milestones
Legend is developing Carvykti in a global partnership with Johnson & Johnson (J&J, NYSE: JNJ) subsidiary Janssen Biotech and secured a first approval for the drug in the United States as a fourth-line multiple myeloma treatment in March 2022. The market approval filing for the drug was accepted for review by the National Medical Products Administration (NMPA) in December 2022. Carvykti is the subject of multiple ongoing studies intended to advance its indications to earlier stages of treatment, including first-line.-Fineline Info & Tech
