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
12-17-20 0724ET
