NEW YORK CITY (dpa-AFX) - Friday, Bristol Myers Squibb (BMY) and 2seventy bio, Inc. (TSVT) announced they received the U.S. Food and Drug Administration approval for Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, based on results of Phase 3, open-label KarMMa-3 trial.
Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells.
This approval expands Abecma's indication and it will be available to patients who have relapsed or become refractory after exposure to these three main classes of treatment, after two prior lines of therapy.
Bryan Campbell, Head of Commercial, Cell Therapy at Bristol Myers Squibb said, 'Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey.'
Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy. It is also currently approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.
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