NGS - Bristol Myers wins positive CHMP opinion for Abecma in multiple myeloma

Bristol Myers Squibb (BMY) announces that the EMA's Committee for Medicinal Products for Human Use ((CHMP)) has recommended granting Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), the company’s BCMA-directed chimeric antigen receptor ((CAR)) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies. The CHMP opinion is based on results from Phase 2 KarMMa study evaluating the efficacy and safety of Abecma in 128 patients with heavily pre-treated and highly refractory multiple myeloma.The recommendation will now be reviewed by the European Commission ((EC)), which is expected to deliver its final decision within 67 days of receipt of the CHMP opinion.

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Bristol Myers wins positive CHMP opinion for Abecma in multiple myeloma