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FDA Grants Breakthrough Therapy Designation to Merck Cancer Drug
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.
Can Data and AI Deliver Whole-Person Health?
July 9th 2024Executives in the life sciences and medical device industries see promise in artificial intelligence (AI) and medical technologies, but must also navigate the changing healthcare ecosystem, varied stakeholder needs, and the impact of AI on market access and commercialization strategies.
