Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The sBLA seeks to expand the label for CARVYKTI 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.
“This submission brings us one step closer to potentially helping more patients facing relapsed and refractory multiple myeloma, as we continue to explore the potential of CARVYKTI® in earlier lines of treatment,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “The prospect of bringing this vital treatment option to more patients excites us, and we remain committed to working with the U.S. FDA and our partner, Janssen, to help patients with multiple myeloma around the world.”
The submission is supported by data from the CARTITUDE-4 study, the first international, randomized, open-label Phase 3 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. SOC in the protocol included pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, and pomalidomide and dexamethasone (DPd).
Results from the CARTITUDE-4 study were featured as an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine.1 They will also be presented at the 2023 European Hematology Association (EHA) Hybrid Congress as an oral presentation.
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.
SOURCE: Businesswire