FDA approves first CAR-T therapy for multiple myeloma

29 March 2021

The US Food and Drug Administration on Friday approved Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed genetically-modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma, the agency pointed out.

News of the approval saw shares of the product’s developers - US pharma major Bristol Myers Squibb (NYSE: BMY) and biotech firm bluebird bio (Nasdaq: BLUE) - edge up 1.8% and 1.2%, respectively, and also marks a significant milestone for BMS, making the latter the only company with two approved CAR-T cell therapies with two distinct targets; last month Breyanzi (lisocabtagene maraleucel; liso-cell) was approved by the FDA.

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