Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

Shots:

• The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors who are ineligible for or have elected not to undergo cystectomy
• The ODAC recommendation is based on the results of P-II KEYNOTE-057 study and supports the potential of Keytruda as monothx. to treat patients with NMIBC. Merck expects PDUFA date in Jan’2020, based on priority review
• The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational therapies for use in the treatment of cancer

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