FDA nod for first-line immunotherapy for MSI-H/dMMR metastatic colorectal cancer

On Monday, the US Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

This new approval for Merck & Co’s already blockbuster immuno-oncology therapy cleared for the treatment of numerous oncology indications, marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy, said the FDA, which noted that it collaborated with international agency counterparts on the review of this application as part of Project Orbis.

This approval was granted less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, noted Merck.