Merck & Co.'s Keytruda wins EU approval for colorectal cancer

Merck & Co. Inc.'s blockbuster drug Keytruda received approval from the European Commission to treat a type of colorectal cancer.

Keytruda, or pembrolizumab, can now be marketed in Europe as an initial treatment for adults with colorectal cancer that has spread and has a genetic abnormality called microsatellite instability-high or deficient mismatch repair, or MSI-H/dMMR.

The drug is the first anti-PD-1/L1 therapy approved in the continent for MSI-H/dMMR colorectal cancer patients.

The findings of a phase 3 clinical trial, named Keynote-177 trial, supported the approval. Under the trial, treatment with Keytruda was associated with 40% reduced risk of disease progression or death compared to chemotherapy.

Patients who received Keytruda had a median survival of 16.5 months without their disease getting worse compared to 8.2 months in the chemotherapy group.

Treatment-related adverse events occurred in 22% of patients in the Keytruda arm compared to 66% in the chemotherapy arm.

The EU approval is also valid in the U.K. In June 2020, Keytruda was approved for the same condition in the U.S.