Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food and Drug Administration (FDA) for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or refractory multiple myeloma.

The approval is for Abecma’s use in the treatment of relapsed or refractory multiple myeloma in adult patients following four or more prior lines of therapy, including an immunomodulatory agent, followed by a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Abecma is now the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy to have been approved for the indication.

The CAR T cell immunotherapy is being developed and commercialized jointly by Bristol Myers Squibb and bluebird bio in the US under a co-development, co-promotion, and profit share agreement between the parties.

Abecma is a customized immune cell therapy, which has to be given as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.

According to Bristol Myers Squibb, the anti-BCMA CAR T cell therapy recognizes and binds to BCMA, a protein that is almost expressed universally on cancer cells in multiple myeloma, resulting in the death of BCMA-expressing cells.

Commenting on Abecma FDA approval, Samit Hirawat – chief medical officer of Bristol Myers Squibb, said: “CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response.

“Bristol Myers Squibb is now the only company with two approved CAR T cell therapies with distinct targets of CD19 and BCMA. As our second FDA-approved CAR T cell therapy, Abecma underscores our commitment to deliver on the promise of cell therapies for patients who are battling aggressive and advanced blood cancers with limited effective treatment options.”

Abecma FDA approval has been driven by results from the phase 2 KarMMa clinical trial that involved 127 patients with relapsed or refractory multiple myeloma who had been subject to at least three prior lines of therapy.

In the mid-stage clinical trial, the overall response rate (ORR) for the efficacy of Abecma in the evaluable population was 72%, while 28% of patients had a stringent complete response.

Nick Leschly – CEO of bluebird bio, commenting on Abecma FDA approval, said: “Our journey to today’s approval of Abecma started nearly a decade ago with pioneering research at bluebird bio and has been driven ever since by our mission to provide patients with multiple myeloma a new approach to fight this relentless disease. This achievement would not have been possible without all of the patients, caregivers, investigators and healthcare staff who participated in our clinical studies, as well as the tremendous collaboration with the FDA.

“Today’s announcement represents an important milestone for bluebird bio, marking both our first approved treatment in oncology and our first approved treatment in the United States.”

  Abecma, bluebird bio, Bristol-Myers Squibb, FDA, Multiple myeloma, Nick Leschly, Oncology, Samit Hirawat, US Food and Drug Administration, USA