European Commission approve idecabtagene vicleucel (Abecma) for relapsed and refractory multiple myeloma

Approval is based on data from the KarMMa trial (n=128) which found an overall response rate of 73% and a complete response rate of 33% Onset of response was reported to be rapid with a median time to response of one month.

SPS commentary:

Due to the risk of cytokine release syndrome and neurologic toxicities, Abecma is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

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