Merck: FDA Grants Priority Review to Keytruda Plus Chemotherapy to Treat Types of Gastrointestinal Cancer

By Mary de Wet

Merck said Thursday that the U.S. Food and Drug Administration has granted priority review for the use of its major drug Keytruda with chemotherapy for the first-line treatment of certain types of esophageal and gastroesophageal cancer.

The approval of the supplemental biologics license application was based on data from a Phase 3 trial that showed Keytruda plus platinum- and fluoropyrimidine-based chemotherapy showed improvements in the primary endpoints of overall survival and progression-free survival in patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction, Merck said.

Keytruda is approved in the U.S., China and Japan as a monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus, the company said.

Merck reported third-quarter sales of Keytruda rose 21%, to $3.7 billion, representing about one-third of Merck's pharmaceutical revenue.

Merck said it is continuing to study Keytruda across multiple settings and stages of gastrointestinal cancer--including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers--through its broad clinical program.

Write to Mary de Wet at mary.dewet@wsj.com

(END) Dow Jones Newswires

December 17, 2020 07:24 ET (12:24 GMT)

Merck (NYSE:MRK)
Historical Stock Chart
From Aug 2024 to Sep 2024