Janssen and Legend Biotech Report the sBLA Submission of Carvykti (ciltacabtagene autoleucel) to the US FDA for Relapsed or Refractory Multiple Myeloma
- The company has submitted sBLA to the US FDA seeking approval of a new indication for Carvykti to treat adult patients with r/r MM. The application was based on the P-III study (CARTITUDE-4) evaluating Carvykti vs PVd or DPd in 419 patients
- The results showed a 74% reduction in risk of disease progression or death at a median follow-up of 16mos., m-PFS (not reached vs 11.8mos.), PFS at 12mos., (76% vs 49%), ORR (85% vs 67%), CR & better (73% vs 22%), patient evaluable for MRD status (144 vs 101), MRD negativity (88% vs 33%) at the 10-5 threshold. The results will be presented at EHA 2023
- Carvykti, a BCMA-directed, genetically modified autologous T-cell immunotherapy was approved in the US in Feb 2022 for r/r MM
Ref: PRNewswire | Image: Janssen
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