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FDA Approves Bristol Myers Squibb and bluebird bio’s CAR T Cell Therapy for Refractory Multiple Myeloma
Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Bristol Myers Squibb and bluebird bio announced on March 26, 2021 that FDA has approved Abecma, the first B-cell maturation antigen-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.
The CAR T cell therapy, which is being jointly developed and commercialized by the companies, was approved after positive data from a Phase II trial showed ide-celelicited rapid responses in the majority of the 127 patients participating in the study, Bristol Myers Squibb said in a company press release.
“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, MD, chief medical officer, Bristol Myers Squibb, in the press release. “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.”
“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,” said Nick Leschly, chief bluebird, bluebird bio, in the press release. “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.”
Source: Bristol Myers Squibb