UPDATED: Bristol-Myers' pioneering PD-1 drug Opdivo OK'd by FDA for melanoma

Bristol-Myers Squibb ($BMY) has won a pioneering FDA approval for Opdivo (nivolumab), its top therapeutic asset in the pipeline, as a new therapy for melanoma.

The FDA announced the approval today, noting that it will become available for the estimated 76,100 Americans diagnosed with the most common form of skin cancer. Like Merck's ($MRK) rival drug Keytruda, which beat Opdivo to the U.S. market, the drug blocks PD-1, a key mechanism that cancer cells use to escape detection by the immune system. And this is only an initial OK for what is widely expected to be a series of approvals ahead for other cancer types.

A spokesperson for Bristol-Myers tells FierceBiotech that the average cost per patient will be $12,500 a month. At $150,000 a year, that's the same price Merck is charging for Keytruda for the same indication.

The approval, which comes more than three months ahead of schedule, clears Opdivo for use on patients with advanced skin cancers who have already taken the company's own Yervoy (ipilimumab). It's also the latest in a string of drug approvals in the past few years that has radically changed the treatment landscape for melanoma patients.

Dr. Richard Pazdur

"Opdivo is the 7th new melanoma drug approved by the FDA since 2011," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases."

Both Opdivo and Keytruda, along with similar programs at Roche ($RHHBY) and AstraZeneca ($AZN), represent the cutting edge of a new wave of drugs that can finally start to unleash a major immune response to cancer for many patients. Merck currently has a program that involves more than 30 cancer types, and each of the contenders is carrying out combination studies designed to determine how well PD-1- and PD-L1-blocking therapies can work in tandem with other oncology treatments.

Bristol-Myers' recent success with Opdivo in non-small cell lung cancer persuaded Leerink's Seamus Fernandez to boost 2020 sales projections for this drug from $4.8 billion to a whopping $7.3 billion, leading the top contenders from Roche, Merck and AstraZeneca.

Analysts expect the whole class of therapies to bring in roughly $35 billion a year at its peak, provided these drugs can live up to the excited hype surrounding their prospects.

- here's the release

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