FDA slaps new bladder cancer limits on Merck's Keytruda, Roche's Tecentriq

Last month, the FDA warned that immuno-oncology stars from Merck and Roche might actually be hurting some previously untreated bladder cancer patients’ survival chances. And now, it’s followed up by narrowing the drugs’ labels.

The agency has restricted use of Merck’s Keytruda and Roche’s Tecentriq among patients with locally advanced or metastatic bladder cancer who aren’t eligible for cisplatin-containing chemo. Specifically, within that population, Keytruda is now OK’d only for patients whose tumors express levels of the biomarker PD-L1 that meet a combined positive score of 10 or higher. Tecentriq, meanwhile, can only be used for those whose PD-L1 immune cells cover 5% or more of their tumor area.

Patients who aren’t eligible for any platinum-containing therapy can still take either drug, regardless of their PD-L1 status, regulators said.

The moves follow findings announced in May that in each of two studies—one testing Keytruda and the other testing Tecentriq—patients with low PD-L1 levels treated with the drugs saw their survival chances sink compared with those who took platinum chemotherapy.

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The FDA’s review of the situation is ongoing, it said, and it will continue to communicate new information regarding the drugs as it rolls in. For now, though, it recommends that cisplatin-ineligible patients with low PD-L1 levels continue taking the drugs in question, as long as they’re responding to therapy.

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The changes mark a setback for both Merck and Roche in an ultracompetitive area. Bladder cancer is the only field in which all five members of the PD-1/PD-L1 class—which also includes AstraZeneca’s Imfinzi, Bristol-Myers Squibb’s Opdivo and Merck KGaA and Pfizer’s Bavencio—boast approvals.

As the agency was quick to point out, though, it hasn’t changed the indications for Keytruda and Tecentriq patients who have seen their disease progress after other therapies, and patients taking the drugs for other approved uses “should continue to take their medication as directed by their health care professional,” it said.