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Pharmaceuticals / Submissions and Approvals

Merck’s Keytruda Given Green Light by FDA

Nov. 20, 2018

Merck’s anti-PD-1 therapy, Keytruda, received approval from the FDA for treating adult patients with hepatocellular carcinoma (HCC) — a common type of liver cancer — that have previously been treated with sorafenib.

The FDA granted the accelerated approval based on data from a single-arm, open-label, multicenter trial that evaluated the use of Keytruda in 104 patients with HCC who experienced disease progression on or after sorafenib or were intolerant to it.

Keytruda’s approval is the second HCC drug in Merck’s cancer treatment portfolio that the agency approved this year.

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