The application includes data from five uncontrolled, open-label, multicohort, multisite phase I/II trials designed to evaluate the humanized monoclonal antibody’s activity in MSI-H cancer patients.
The FDA set a target action date of 8 March 2017. Keytruda has FDA breakthrough therapy status for unresectable or metastatic MSI-H non-colorectal cancer, and for unresectable or metastatic MSI-H colorectal cancer.
Merck Research Laboratories president Roger Perlmutter said: “The FDA’s acceptance of this application represents an important advance for the field of immuno-oncology and is further evidence of Merck’s commitment to identifying patients most likely to benefit from Keytruda treatment.
“We believe that patients whose tumors harbor DNA repair defects may be especially responsive to Keytruda, and we look forward to working with the FDA to bring this important new therapy to these very challenging treatment situations.”
Keytruda increases the ability of the body’s immune system to help identify and fight tumor cells.
Keytruda is already approved to treat patients with unresectable or metastatic melanoma, certain patients with metastatic non–small cell lung cancer, and patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.
Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.