Bristol-Myers Squibb gets USFDA nod to multiple myeloma therapy
New Delhi: 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.