Posted by Michael Wonder on 09 Jun 2017
Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration
22 December 2014 - First approval of Opdivo in the United States.
Bristol-Myers Squibb Company today announced that the U.S. FDA approved Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Metastatic melanoma is the deadliest form of skin cancer, and despite recent advances, there are limited treatment options available for patients who have been previously treated with approved agents.
