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FDA Grants Breakthrough Therapy Designation to Merck Cancer Drug

Article

November 11, 2015.

FDA News reports that FDA has granted breakthrough therapy designation to Merck’s Keytruda, an anti-PD-1 therapy for treating patients with microsatellite instability high metastatic colorectal cancer.

The breakthrough designation is based on Phase 2 data of the drug’s activity in cancers with microsatellite instability, a feature present in cells with certain types of DNA repair defects.

Merck is conducting a Phase 3 study of the drug in a treatment-naïve patient population.

Keytruda (pembrolizumab) previously was granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer.

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