- Much of the focus on the rapidly growing immuno-oncology market has centered on the lucrative lung cancer drugs. But, as regulatory actions by the Food and Drug Administration have shown, bladder cancer is quickly becoming a competitive indication as well.
- Last week, the FDA approved Bristol-Myer Squibb's Opdivo (nivolumab) for second-line treatment of bladder cancer and accepted two applications from Merck & Co. for approval of Keytruda (pembrolizumab) in the same indication, plus as a first-line agent for cisplatin-ineligible patients.
- Roche's Tecentriq (atezolizumab) currently has a commanding lead in the bladder cancer market, but Opdivo and Keytruda could soon cut in on Roche's share. And AstraZeneca, which is hoping to avoid becoming an also-ran in I/O, recently filed for approval of its checkpoint inhibitor durvalumab in bladder cancer as well.
Roche, which entered the immuno-oncology market third behind Merck and Bristol-Myers, aimed first for the bladder cancer space, hoping to establish market share there before building into other indications.
Its checkpoint inhibitor Tecentriq (atezolizumab) is currently approved for second-line treatment in advanced or metastatic urothelial cancer. And the FDA accepted an application for Roche for a first-line approval in January, setting up a regulatory decision by April 30, 2017.
"Tecentriq [has had] a good start in bladder cancer, with about 60% penetration in the market. It has become the standard of care in second line and a portion of first line [treatment]," said Daniel O'Day, head of Roche Pharmaceuticals, on a conference call discussing the company's 2016 results.
Opdivo, though, will soon be on the market competing with Tecentriq, although recent clinical setbacks for Bristol-Myers' star in lung cancer have taken some of the luster away from Opdivo's profile.
More competition is inbound. The FDA has set a target action date of June 14 for deciding on approval of Merck's Keytruda in bladder cancer. AstraZeneca's durvalumab could also be approved for the second-line indication sometime in the second quarter.
While much attention is given to lung cancer, bladder cancer is an area of unmet need, with an estimated 77,000 new diagnoses and over 16,000 deaths in 2016 in the U.S. alone. Urothelial cancer makes up around 90% of all bladder cancers.
The immuno-oncology race in lung cancer has already seen major shifts since Opdivo's failure in first-line treatment. To date, Roche has had the bladder cancer market all to itself. The next year could see major changes in market make-up, although Tecentriq has built a lead.