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news.The US Food and Drug Administration (USFDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy.
USFDA approval is based on the results of Phase II KarMMa trial. (Credit: National Cancer Institute on Unsplash.)
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The US Food and Drug Administration (USFDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy.
Abecma is a BCMA-directed personalised immune cell therapy, which is used for the treatment of adult patients suffering from relapsed or refractory multiple myeloma, following four or more prior lines of therapy.
Myeloma includes an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The therapy is delivered as a one-time infusion for triple-class exposed patients with multiple myeloma, which it recognises and binds to BCMA.
BCMA is a protein that is nearly universally expressed on cancer cells in multiple myeloma, which leads to the death of BCMA-expressing cells.
The USFDA approval is based on the results of the Phase II KarMMa trial conducted on 127 patients with relapsed or refractory multiple myeloma.
These patients have previously received at least three lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Bristol Myers Squibb chief medical officer Samit Hirawat said: “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.”
The company noted that the new therapy is being developed and commercialised in the US as part of a co-development, co-promotion and profit share agreement signed with bluebird bio.
