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# Merck’s Keytruda Approved for Cervical Cancer
- URL: https://www.fdaweb.com/mercks-keytruda-approved-for-cervical-cancer/
- Published: 2018-06-12T12:00:00.000Z
- Updated: 2026-09-15T00:12:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141667

FDA has approved Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test. The indication was given accelerated approval based on tumor response rate and durability of response, Merck says. It was based on data from 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort (Cohort E) in study KEYNOTE-158, a multi-center, non-randomized, open-label trial. For the 77 patients whose tumors expressed PD-L1, the objective response rate was 14.3%, with a complete response rate of 2.6% and partial response rate of 11.7%. Among the 11 responding patients, 91% experienced a duration of response of six months or longer, the company says.