FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma

Merck/MSD

23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting.

Merck announced today that the U.S. FDA has accepted for review a supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. 

The FDA granted priority review with a PDUFA, or target action, date of 22 September 2017.

Read Merck press release

Michael Wonder

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Michael Wonder