(Reuters) – Bristol Myers Squibb said on Wednesday the U.S. drug regulator had extended the review of its experimental blood cancer therapy by three months after the drugmaker submitted additional information to the agency.
The company said the information was considered a major amendment to its marketing application and it would work closely with the U.S. Food and Drug Administration as it reviews the therapy.
Bristol now expects the agency to announce its decision by Nov. 16 on the therapy known as liso-cel, which it acquired as part of its $74 billion buyout of Celgene Corp.
As part of the buyout agreement, Celgene investors are entitled to received a contingent value right payment of $9 a share if three treatments in development, including liso-cel, achieve timely approvals.
Liso-cel, which is developed for relapsed or refractory large B-cell lymphoma, belongs to a class of therapies known as CAR-T cell therapy. The treatment takes immune cells from a patient, engineers them to attack cancer and infuses them back into the patient.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Amy Caren Daniel)
