Bristol Myers Squibb receives a positive opinion from the CHMP for the CAR T cell therapy Abecma (idecabtagene vicleucel) in previous treatment lines for relapsed and refractory triple class multiple myeloma.)

This recommendation for approval is based on the KarMMa-3 phase 3 study, in which Abecma demonstrated superiority over standard treatment regimens.

This is the first positive CHMP opinion concerning previous lines of therapy for chimeric antigen receptor (CAR) T-cell therapy in relapsed and refractory multiple myeloma.

The European Commission's approval would expand Abecma's indication, making it the first CAR T cell therapy available in the European Union (EU) for patients with relapsed and refractory multiple myeloma exposed to a triple class earlier in the treatment pathway.

"This positive CHMP opinion represents an important step towards making our first potentially transformative anti-BCMA CAR T cell therapy, Abecma, available to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes," said Anne Kerber, M.D., Senior Vice President and Head of Late Stage Clinical Development, Hematology, Oncology and Cellular Therapy (HOCT), Bristol Myers Squibb.

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