Merck’s checkpoint star Keytruda grabs another FDA OK, steering past wreckage of a Roche disaster
Merck’s Keytruda continues to make a rapid advance to new approvals for expanded use. This time the FDA is approving their PD-1 drug for second-line as well as some first-line cases of bladder cancer — while Roche’s landmark OK for the rival Tecentriq (atezolizumab) in the same indication has been threatened by a stunning Phase III failure.
Regulators came up with an accelerated approval for Keytruda for patients whose advanced cases of urothelial cancer have progressed after chemotherapy as well as any frontline patients who aren’t eligible for cisplatin-containing chemotherapy. KEYNOTE-045 provided the data for the second-line OK, with an objective response rate of 21% for Keytruda, close to twice that achieved by chemotherapy. Those numbers underscore the promise for this field, as well as the need for combination therapies that can do much better. And Merck has hundreds of those underway now.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.