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Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK

June 11, 2019 / Carly Helfand

Tuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients. Regulators green-lighted the immuno-oncology star as monotherapy in patients whose tumors bear the biomarker PD-L1 and in combination with a commonly used chemo regimen in patients regardless of PD-L1 status. The regulatory wins follow a quick review from the agency, which bestowed its priority designation on Keytruda back in February. FDA staffers based the speed-up on data showing that that, when facing off against a standard-of-care regimen commonly referred to by the name “Extreme,” Keytruda could lower the risk of death by 22% in PD-L1 positive patients. And when paired with chemo, Keytruda slashed the risk of death by 23% regardless of patients’ PD-L1 status.