Another 'Breakthrough' designation for Merck's Keytruda from FDA

The US Food and Drug Administration has granted Breakthrough Therapy designation to Keytruda (pembrolizumab), US pharma giant Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy designation granted for Keytruda.

Keytruda was previously granted Breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC). Keytruda is indicated in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Keytruda is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

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