BMS Receives Accelerated Approval of Opdivo (Nivolumab) from FDA

Bristol-Myers Squibb Company (BMS) has announced that the 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.

“BMS is pleased to be able to offer an important new option for patients who have progressed following treatment for unresectable or metastatic melanoma, which is one of the most aggressive forms of cancer,” said Lamberto Andreotti, CEO, BMS. “The approval of Opdivo, the latest breakthrough medicine from our immuno-oncology pipeline, demonstrates our company’s commitment to meeting the needs of these patients, and to leading advances in the science of immuno-oncology.”

Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, hypothyroidism and hyperthyroidism, other adverse reactions; and embryofetal toxicity.

The company expects to begin shipping Opdivo within one to two weeks of today’s (22 December 2014) approval.