Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is written in the approval document as:

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib