Regulatory approval

Published by the European Medicines Agency. Approved

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS >= 10 and who have not received prior chemotherapy for metastatic disease.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
EMA (1) ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative Invasive Breast Carcinoma Paclitaxel, Pembrolizumab
EMA (1) ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative Invasive Breast Carcinoma Carboplatin, Gemcitabine, Pembrolizumab
EMA (1) ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative Invasive Breast Carcinoma Nab-paclitaxel, Pembrolizumab

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2021-10-19 European Medicines Agency Indication received approval from the European Commission.