Merck Gets Positive Opinion From EU's CHMP on Keytruda for Types of Colorectal Cancer

By Mary de Wet

Merck said Friday that Keytruda received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency that recommended approval of the anti-PD-1 therapy as first-line treatment of certain types of colorectal cancer.

The recommendation followed a Phase 3 trial in which Keytruda was used as a monotherapy for adults with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The study demonstrated a significant improvement in progression-free survival compared with chemotherapy, Merck said.

The CHMP's recommendation will be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021, Merck said.

Keytruda increases the ability of the body's immune system to help detect and fight tumor cells, the company said. The drug is being tested against other cancers as well.

In the third quarter, Merck reported sales of Keytruda were up 21% to $3.72 billion from a year ago.

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

(END) Dow Jones Newswires

December 11, 2020 07:49 ET (12:49 GMT)

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