EC green light for Abecma in multiple myeloma

Adding to US regulatory clearance in March this year, US pharma major Bristol Myers Squibb (NYSE: BMY) has now won conditional approval for its a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy Abecma (idecabtagene vicleucel; ide-cel) from the European Commission.

The EC approval of Abecma, which was co-developed with US biotech bluebird bio (Nasdaq: BLUE), is for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

BMS says that Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells. Abecma is delivered via a single infusion with a target dose of 420 x 10 CAR-positive viable T cells within a range of 260 to 500 x 10-positive viable T cells.