- Bristol-Myers Squibb on Monday said the Food and Drug Administration had granted its immunotherapy Opdivo a breakthrough therapy designation for treatment of bladder cancer, setting up potential competition with Roche's newly-approved Tecentriq.
This is the sixth breakthrough designation granted to Bristol-Myers for Opdivo, with the FDA having previously tagged the drug for expedited review in lung cancer, melanoma, kidney cancer, Hodgkin's lymphoma, and squamous head and neck cancer.
- Bristol-Myers said it plans to submit Opdivo for approval in bladder cancer sometime in the coming months.
Merck and Bristol-Myers have been locked in a battle for market share in the immuno-oncology space. Although Merck's Keytruda beat Opdivo to market in the U.S., Opdivo has since surpassed its competitor and racked up approvals across a number of cancer indications.
The field got a little more crowded in May when Roche's Tecentriq won FDA approval for the most common form of bladder cancer.
All three drugs are so-called checkpoint inhibitors and target the same PD1/PDL1 pathway. While Roche is testing Tecentriq against a wide-array of cancers, the company aimed for bladder cancer first in hopes of carving out a niche for itself.
A breakthrough designation only indicates preliminary clinical evidence showed the drug may offer substantial improvements over current standard-of-care. But it does gives drugmakers greater consultation access with the FDA and sets up the drug for an expedited review.
The need in bladder cancer is there: Roughly 80,000 new cases of bladder cancer are reported in the U.S. each year, and many of those patients will relapse, necessitating second-line treatment options. Until the approval of Tecentriq last month, there had been no new approved treatments for bladder cancer in 30 years.
Bristol-Myers will have to hope the market need will help it steal some market share, as Roche will have a hefty head start.