FDA approves Bristol-Myers Squibb's Opdivo for advanced melanoma

The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs.

The company says it expects to begin shipping Opdivo within one to two weeks of yesterday’s approval. BM-S officials said the company plans to charge an average of $12,500 a month for the treatment, the same price as the rival drug Keytruda, according to the Wall Street Journal.

The drug is the second PD-1 inhibitor to be approved by the FDA, the first being Merck & Co (NYSE: MRK) Keytruda (pembrolizumab) in September. Swiss pharma major Roche (ROG: SIX) and Anglo-Swedish AstraZeneca (LSE: AZN) are also developing PD-1 inhibitors for different kinds of cancers. Opdivo was launched earlier this year in Japan at an average annual cost of $143 000, marking the first PD-1 inhibitor to be commercialized anywhere in the world, noted a Reuters report.