Merck Gets CHMP Backing of Keytruda in Gastrointestinal Cancer

By Colin Kellaher

Merck & Co. Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug Keytruda in certain types of gastrointestinal cancers.

The Kenilworth, N.J., drugmaker said the recommendation covers Keytruda in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (CPS >=10).

Merck said the positive CHMP opinion is based on results from the a phase 3 study in which Keytruda plus 5-fluorouracil and cisplatin showed significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in patients regardless of histology or PD-L1 expression status.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision in the second quarter, Merck said.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 24, 2021 07:14 ET (11:14 GMT)

Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024