Regulatory approval

Published by the Food and Drug Administration. Approved

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is written in the approval document.

Citation

AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.

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Therapeutic response

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

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