Bristol Myers Squibb and bluebird bio get US FDA nod for Abecma (idecabtagene vicleucel) to treat relapsed or refractory multiple myeloma

Bristol Myers Squibb and bluebird bio announced that the US Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (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. Abecma is a personalised immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 10 CAR-positive T cells. As an anti-BCMA CAR T cell therapy, Abecma recognises 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.

“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,” said Samit Hirawat, Chief Medical Officer, Bristol Myers Squibb.

“Bristol Myers Squibb is now the only company with two approved CAR T cell therapies with distinct targets of CD19 and BCMA,” he added.

Nick Leschly, chief bluebird, bluebird bio said, “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.”

Despite advances in treatment, multiple myeloma remains an incurable disease characterised by periods of remission and relapse. Most patients experience a relapse following initial therapies, and the depth and duration of response, as well as survival outcomes, decrease with each successive treatment. Patients with relapsed or refractory multiple myeloma that have been exposed to all three major drug classes (triple-class exposed), including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, tend to demonstrate poor clinical outcomes with very low response rates (20% to 30%), short duration of response (2 to 4 months) and poor survival.

Abecma will be manufactured for each individual patient using the patient’s own T cells at Bristol Myers Squibb’s cellular immunotherapy manufacturing facility in Summit, New Jersey. The lentiviral vector, which is used to engineer the CAR T cells, was developed by bluebird bio.

 Abecma is being jointly developed and commercialised in the US as part of a co-development, co-promotion and profit share agreement between Bristol Myers Squibb and bluebird bio.