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# Keytruda Plus Chemo Approved for Cervical Cancer
- URL: https://www.fdaweb.com/keytruda-plus-chemo-approved-for-cervical-cancer/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150357

FDA has approved Merck’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1\. The agency also granted full approval to the therapy’s previous accelerated approval as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.

FDA’s decisions were based on data from the KEYNOTE-826 (NCT03635567) study that evaluated overall survival (OS) and progression-free survival (PFS). [According to FDA](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancer?ref=fdaweb.com), median OS was not reached in the pembrolizumab arm and was 16.3 months in the placebo arm. Median PFS was 10.4 months in the pembrolizumab arm and 8.2 months in the placebo arm. “The objective response rates were 68% (95% CI: 62, 74) and 50% (95% CI: 44, 56) with median DoR \[duration of response\] of 18.0 and 10.4 months in the pembrolizumab and placebo arms, respectively,” the agency says.