U.S. FDA approves Bristol-Myers Squibb's multiple myeloma therapy

Reuters
·1 min read
FILE PHOTO: Logo of global biopharmaceutical company Bristol-Myers Squibb is pictured on the blouse of an employee in Le Passage

(Reuters) - The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co and bluebird bio Inc's multiple myeloma therapy, ide-cel, acquired as part of its $74 billion buyout of Celgene, the drugmakers said in a joint statement late on Friday.

Ide-cel is a CAR-T therapy that involves taking immune cells from a patient, engineering them to attack tumor cells and infusing them back into the patient.

Bristol Myers Squibb and partner bluebird bio Last year resubmitted its application for ide-cel after the U.S. drug regulator declined to review the treatment and sought more information.

As part of the Celgene-Bristol Myers deal, Celgene shareholders would have received a $9 per share payment if three of Celgene's top pipeline assets were approved by certain dates.

However, the FDA did not approve blood cancer therapy, liso-cel, by the end of 2020 and as a result the CVR agreement was terminated. (https://bit.ly/3lS3Gn8)

(Reporting by Mrinalika Roy and Anirudh Saligrama in Bengaluru; Editing by Simon Cameron-Moore)