Bristol-Myers races to the FDA with immuno-oncology star nivolumab

Bristol-Myers Squibb ($BMY) plans to submit its closely watched cancer candidate nivolumab for FDA approval to treat melanoma next quarter, outpacing analysts' expectations and setting the stage for a duel with Merck's ($MRK) rival drug.

The drug, nivolumab, is a cancer treatment designed to galvanize the immune system against a wide range of tumor cells by blocking a pathway called PD-1. Bristol-Myers' planned application would cover melanoma patients previously treated with the company's own Yervoy, and, if approved, the drug would trade under the name Opdivo.

The filing is well ahead of Wall Street's expectation of a mid-2015 submission, according to ISI Group analyst Mark Schoenebaum, and the accelerated move puts Bristol-Myers about 8 months behind Merck, whose PD-1-blocking pembrolizumab (MK-3475) is expected to get final word on its melanoma application by Oct. 28.

Meanwhile, Bristol-Myers is working through a rolling FDA submission for nivolumab in non-small cell lung cancer, expecting to complete the filing by year's end. And the company is bankrolling a sweeping clinical program for the promising drug, studying its effects on renal cell carcinoma, head and neck cancer, glioblastoma, and non-Hodgkin lymphoma, among other cancers.

At stake is the largest share of a PD-1 market projected to peak as high as $35 billion a year, and Bristol-Myers is racing with Merck, AstraZeneca ($AZN), Roche ($RHHBY) and others to string together FDA approvals and capitalize on stellar data for the whole class.

And while Merck is almost certain to hit the U.S. market first, nivolumab became the first PD-1 inhibitor approved anywhere in the world when it picked up a Japanese nod earlier this week.

- read the statement