Merck's Keytruda Is First Checkpoint Inhibitor To Win US Approval Based On TMB Biomarker
Merck has secured FDA approval for Keytruda for use in tumors with high tumor mutational burden, something Bristol's Opdivo and AstraZeneca's Imfinzi were not able to do in lung cancer.
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Merck’s anti-PD-1 therapy Keytruda keeps piling up new indications, including three approved by US FDA in just two weeks – all during a pandemic. The remarkable therapy has been a centerpiece for an equally remarkable period of regulatory innovation.
Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Pembrolizumab should be considered the new standard of care as first-line therapy in patients with microsatellite instability high (MSI-H) metastatic colorectal cancer, KEYNOTE-177 investigator André said.