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Early, early, early. Bristol-Myers Squibb has been on a sprint with Opdivo in a new group of melanoma patients-with an early trial halt, a quick unveiling of detailed data, and now, a speedy review at the FDA for a new approval.
The agency put Opdivo in the fast lane as a treatment for high-risk melanoma patients whose tumors have been surgically removed, based on data from a study, called Checkmate-238, that tested the immunotherapy against its fellow Bristol-Myers drug Yervoy.
The idea is to prevent the cancer from coming back rather than waiting to treat a recurrence, Fouad Namouni, M.D., Bristol-Myers' head of oncology development, told FiercePharma when the study data was released last month. “At the...