Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Pembrolizumab in patients with Cervical Adenocarcinoma.

The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of 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.

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.