Bristol Myers Squibb, a leading biopharmaceutical company based in New York, announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of earlier use of their Abecma gene therapy. This therapy is being developed in collaboration with 2seventy bio.
The recommendation specifically pertains to the use of Abecma earlier in the treatment course for individuals diagnosed with the blood cancer multiple myeloma. This promising advancement in treatment options will now undergo a review by the European Commission.
If approved, Abecma will become the first chimeric antigen receptor T-cell (CAR-T) cell therapy available in the European Union for patients with triple-class exposed relapsed and refractory multiple myeloma at an earlier stage of their treatment.
Bristol Myers and 2seventy, a biotechnology company based in Cambridge, Massachusetts, are partnering to develop and commercialize Abecma in the United States. Bristol Myers takes responsibility for manufacturing and commercialization outside of the U.S.
In November, the companies also announced that the U.S. Food and Drug Administration is planning to hold an advisory committee meeting to discuss a similar earlier approval for Abecma. As a result, the agency's review will extend beyond its original target action date of December 16th.