Shares of bluebird bio, Inc. BLUE gained 3.2% after the company and its partner Bristol Myers (NYSE:BMY) Squibb BMY announced that the FDA has approved their chimeric antigen receptor (CAR) T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.
The regulatory agency approved Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The immunotherapy is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
The FDA nod was based on data from the pivotal phase II KarMMa study of 127 patients with relapsed or refractory multiple myeloma. The efficacy evaluable population consists of 100 patients who received Abecma within the dose range of 300 to 460 x 106 CAR-positive T cells. 88% of these patients received four or more prior lines of therapy while 85% was triple-class refractory. The overall response rate (ORR) for the efficacy evaluable population was 72% while 28% of patients achieved a stringent complete response.
The approval lends a significant boost to bluebird on two counts, marking its first approved treatment in oncology as well as its first approved treatment in the United States.
Shares of the company have plunged 32.9% in the year-to-date period compared with the industry’s decline of 3.6%.
For Bristol Myers, this is the second CAR T cell therapy approved after Breyanzi, which got the nod for adults with relapsed or refractory large B-cell lymphoma.
Other approved CAR T cell therapies in the United States include Gilead’s GILD Yescarta and Novartis’ NVS Kymriah.
bluebird bio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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