Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy with or without bevacizumab for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. This indication is based on KEYNOTE-826 (NCT03635567), a multicenter, randomized, double-blind, placebo-controlled trial where patients received one of the following as the chemotherapy portion of their treatment regimen: cisplatin and paclitaxel; bevacizumab, cisplatin, and paclitaxel; carboplatin and paclitaxel; bevacizumab, carboplatin, and paclitaxel.
This is written in the approval document as:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.
Citation
Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s174lbl.pdf. Revised April 2025. Accessed April 30, 2025.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Adenocarcinoma | Cisplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Squamous Cell Carcinoma | Cisplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Adenocarcinoma | Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Squamous Cell Carcinoma | Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Adenocarcinoma | Carboplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Squamous Cell Carcinoma | Carboplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Adenocarcinoma | Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Cervical Squamous Cell Carcinoma | Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab |