The US Food and Drug Administration will consider a submission for novel cancer therapy ciltacabtagene autoleucel (cilta-cel) under the agency’s Priority Review scheme, with a decision expected by November 29.
The BCMA-directed CAR-T cell therapy, developed by Legend Biotech (Nasdaq: LEGN), is being investigated as a treatment for multiple myeloma as a later line option.
Backed by data from the Phase Ib/II CARTITUDE-1 study, the therapy has already been submitted for marketing authorization with the European Medicines Agency (EMA).
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