Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy and with or without bevacizumab for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 with a combined positive score (CPS) >= 1. This indication is based on KEYNOTE-826, a multicenter, randomized, double-blind, and placebo-controlled study that studied the efficacy of pembrolizumab in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab in 617 patients meeting this indication's clinical criteria.

This is written in the approval document as:

KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS >= 1.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.

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	Carboplatin, Paclitaxel, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab