Data from Pharmawand - Curated by EPG Health - Date added 14 March 2018

Merck announced that the FDA has accepted a new supplemental Biologics License Application (sBLA) and granted Priority Review for Keytruda (pembrolizumab), seeking approval as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. This is the first filing acceptance and Priority Review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for Keytruda. The FDA has set a PDUFA, or target action, date of June 28, 2018.

The application to the FDA, which is seeking accelerated approval for this new indication, is based in part on data from the phase II KEYNOTE-158 trial. KEYNOTE-158 is an ongoing global, open-label, non-randomized, multi-cohort, multi-center study evaluating Keytruda in patients with multiple types of advanced solid tumors – including cervical cancer – that have progressed on standard of care therapy.


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