The FDA on October 13, 2021, approved KEYTRUDA® in combination with chemotherapy, with or without Bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. KEYTRUDA® is a product of Merck & Co., Inc.
FDA also granted regular approval to KEYTRUDA® as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. In June 2018, FDA had granted accelerated approval to this indication with the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).