Regulatory approval

Published by the European Medicines Agency. Approved

KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence.

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, PR negative Invasive Breast Carcinoma Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2022-05-19 European Medicines Agency Indication received approval from the European Commission.