Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then continued as a monotherapy for the adjuvant treatment after surgery, of adult patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.

This is written in the approval document as:

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.

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.

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.