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# Merck sBLA for Keytruda in Cervical Cancer Patients
- URL: https://www.fdaweb.com/merck-sbla-for-keytruda-in-cervical-cancer-patients/
- Published: 2018-03-13T12:00:00.000Z
- Updated: 2026-09-14T23:52:59.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140966

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is progressing on or after chemotherapy. This is the first submission for an anti-PD-1 therapy in cervical cancer, and the agency has set a user fee review action target date of 6/28, according to the company. The filing is based on data from the Phase 2 KEYNOTE-158 trial, an ongoing global, open-label, non-randomized study evaluating Keytruda in patients with multiple types of advanced solid tumors — including cervical cancer — that have progressed on standard of care therapy. Keytruda has been approved for 10 other indications, including melanoma, lung cancer, head and neck cancer and Hodgkin lymphoma.