Janssen seeks USFDA nod for Carvykti for relapsed or refractory multiple myeloma
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for 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, an immunomodulatory agent, and are refractory to lenalidomide.
The application is supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The CARTITUDE-4 study results were featured in the press briefing and presented as an oral presentation in a special session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #LBA106) and will be presented in the plenary session (Abstract #S100) at the 2023 European Hematology Association (EHA) Hybrid Congress in Frankfurt on June 10, 2023.
“We are focused on advancing CARVYKTI in the treatment of multiple myeloma, including for patients with relapsed or refractory disease, where we hope to intervene earlier with the goal of transforming outcomes for patients,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
“We look forward to collaborating with the FDA on the review of this application and continuing to bring CARVYKTI to patients who are candidates for this CAR-T therapy.”
In January 2023, Janssen announced the CARTITUDE-4 study met its primary endpoint of significant improvement in progression-free survival at the first pre-specified interim analysis and, as a result, the Independent Data Monitoring Committee recommended the unblinding of the study. The secondary endpoints were safety, overall survival, minimal residual disease negative rate and overall response rate.
