FDA approves pembrolizumab for certain forms of colorectal cancer

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

Approval was based on results from the Phase 3 KEYNOTE-177 trial, in which pembrolizumab significantly reduced the risk of disease progression or death by 40% compared with standard of care, and more than doubled median progression-free survival compared with chemotherapy.

“Today’s approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed Keytruda monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release. “Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.”

Read the full press release here.