Bristol Myers: received a positive opinion from the CHMP

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

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

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

Approval from the European Commission 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 triple class earlier in the treatment pathway.

‘This positive opinion from the CHMP 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 in order to ‘improve outcomes,’ said Anne Kerber, MD, senior vice president and head of late clinical development, hematology, oncology and cellular therapy (HOCT), Bristol Myers Squibb.

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