sBLA submitted to the FDA seeking approval for Carvykti for the earlier treatment of patients with relapsed or refractory multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the 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 III 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 were presented in the plenary session (Abstract #S100) at the 2023 European Hematology Association (EHA) Hybrid Congress in Frankfurt on June 10, 2023.
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