Regulatory approval

Published by the European Medicines Agency. Approved

Lynparza is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

This is written in the approval document.

Citation

AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
EMA (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-08-02	European Medicines Agency	Indication received approval from the European Commission.