FDA Panel Laps Up Merck's Keytruda & Lynparza For New Maladies
Zacks Investment Research | Dec 17, 2019 11:00PM ET
Merck & Co., Inc. (NYSE:MRK) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted (9-4) in favor of approving its blockbuster PD-L1 inhibitor Keytruda for the treatment of patients with high-risk, non-muscle invasive bladder cancer (NMIBC). Currently, there are limited number of non-surgical treatment options available for the given patient population.
The committee’s discussions were based on the supplemental biologics license application (sBLA) for Keytruda, to which the FDA has granted a priority review earlier this month. The sBLA was based on data from the phase II KEYNOTE-057 study. Through this, the company is seeking approval of Keytruda, as a monotherapy to treat certain patients with high-risk NMIBC, unresponsive to the widely-used Bacillus Calmette-Guerin (BCG) therapy in the management of bladder cancer.
With the FDA granting priority review to the sBLA, Merck expects a decision in January 2020. Notably, the regulatory agency is not bound by the committee’s guidance but takes its advice into consideration.
Shares of Merck have rallied 16.5% so far this year compared with the Zacks Investment Research
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