By Colin Kellaher
Bristol Myers Squibb Co. and bluebird bio Inc. on Tuesday said the U.S. Food and Drug Administration granted priority review to their biologics license application for idecabtagene vicleucel, or ide-cel, for the treatment of adults with the blood cancer multiple myeloma.
The companies are seeking approval of the CAR T cell immunotherapy for patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.
Bristol Myers and bluebird said the agency set a target action date of March 27 for the application.
Ide-cel is one of three drugs tied to the contingent value rights Bristol Myers issued to Celgene shareholders as part of its $74 billion takeover and must gain FDA approval by the end of March 2021 to trigger payment.
The FDA in May turned away the companies' initial application for ide-cel with a request for more information. New York-based Bristol Myers and bluebird, a Cambridge, Mass., clinical-stage biotechnology company, resubmitted the application in late July.
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