BMS' Opdivo guns for kidney cancer nod with FDA 'breakthrough' tag

Last July, Bristol-Myers Squibb ($BMY) put an early end to a late-stage study that showed its immunotherapy drug, Opdivo, looked good in patients with advanced kidney cancer. And now, it's one step closer to landing a nod in that population.

The med has scored the FDA's "breakthrough" tag, which will help it on its way to a speedier kidney cancer approval. The agency based the decision on data from Bristol's CheckMate series of Opdivo studies, which marked the first time any checkpoint inhibitor had proven itself in a kidney cancer trial--and the first time any med had demonstrated an overall survival benefit as a primary endpoint compared with the standard of care in the second-line setting.

"The breakthrough therapy designation in advanced renal cell carcinoma is a clear signal of the need for additional treatment approaches for RCC and reflects part of our broad commitment to immuno-oncology research that may address many types of advanced cancers," BMS' oncology SVP, Michael Giordano, in a statement.

Addressing many types of cancers is just what the New Jersey pharma wants to do with Opdivo, which is racing Merck's ($MRK) checkpoint inhibitor, Keytruda, to rack up indications. Though Merck's med was the first to win the FDA's favor, scoring an approval in advanced melanoma, it wasn't long before Opdivo landed that thumbs up--and followed with a lung cancer approval shortly thereafter.

It's not just Keytruda Bristol has to worry about, though. Roche ($RHHBY) has a candidate champing at the bit, and that drug--which targets PD-L1, rather than the PD-1 Opdivo and Keytruda do--recently turned out successful results in a bladder cancer trial. AstraZeneca ($AZN) has its own immunotherapy coming up the pipeline, too.

Still, though, it's Opdivo that analysts predict will ultimately take the checkpoint inhibitor crown. Some have pegged the therapy for $8.2 billion by 2020, which would land it in third on the worldwide sales list. Other industry-watchers predict the checkpoint inhibitor crowd will eventually rack up $33 billion, with Bristol taking 37% of that market.

- read the release

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