Merck announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Keytruda (pembrolizumab) for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer.

The FDA grants Keytruda its third Breakthrough Therapy designation, with previous designations granted for advanced melanoma and advanced non-small cell lung cancer (NSCLC).

The Breakthrough Therapy designation in advanced colorectal cancer is based on data from a Phase 2 study evaluating the activity of Keytruda in cancers with microsatellite instability, a well-established feature seen in cells with certain types of DNA repair defects. Results were presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting and were published in the New England Journal of Medicine.

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Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of Keytruda based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment-naïve patient population. Keytruda is currently being studied in various cancer indications including melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors.

Keytruda is a humanized anti-PD-1 monoclonal antibody currently indicated for the treatment of patients with metastatic NSCLC with PD-L1 tumor expression as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy, and 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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