Bristol Myers: Abecma approved by EU

(CercleFinance.com) - Bristol Myers Squibb's Abecma (idecabtagene vicleucel) becomes the first CAR T cell therapy approved in the European Union in prior lines for relapsed and refractory triple-class exposed multiple myeloma.


Abecma demonstrated superiority over standard treatment regimens in the phase 3 KarMMa-3 trial, with a 51% reduction in the risk of disease progression or death, and a well-established safety profile, with mainly transient and low-grade occurrences of cytokine release syndrome and neurotoxicity.

Today's approval in the European Union marks an important milestone in our efforts to bring the transformative potential of cell-based therapies to the front lines of treatment, it said.

Abecma is an important treatment option for patients with relapsed and refractory triple class multiple myeloma who have received at least two prior therapies: it paves the way for a promising shift in the treatment paradigm.


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