Legendary Bio submitted a supplemental application to the FDA to expand the indication for CARVYKTI®

On June 6, 2023, Legendary Bio announced in Somerset, New Jersey, USA, that it has submitted a Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA). The application aims to expand the indications for CARVYKTI® (ciltacabtageneautoleucel, cilta-cel, Cildacioleucel), Adults with relapsed, lenalidomide-resistant multiple myeloma who had received at least one previous therapy, including a proteasome inhibitor and an immunomodulatory agent, were enrolled.

The application is based on data from the CARTITUDE-4 study (NCT04181827), the first international, randomized, open-label, phase 3 study, To evaluate the efficacy and safety of chidarylorenz versus standard of care (SOC) in adult patients with relapsed lenalidomide-resistant multiple myeloma who had received 1-3 lines of previous therapy. Socs under study included pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

CARTITUDE - 4 results in 2023 the American society of clinical oncology (ASCO) annual meeting (paper # LBA106) oral report, published in the New England journal of medicine and synchronization (TheNewEnglandJournalofMedicine, NEJM). The study data will also be presented orally at the 2023 European Hematology Association (EHA) Hybrid Congress (abstract #S100).

Notably, in January, Legendary Biologics announced that the CARTITUDE-4 study met its primary endpoint of statistically significant improvement in progression-free survival compared with standard of care at the first prespecified interim analysis. Therefore, the independent data monitoring committee recommended unblinding of the study.