Lynparza Approved for Germline BRCA-Mutated Metastatic Breast Cancer

Share this content:
it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation
it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation

The Food and Drug Administration (FDA) has approved Lynparza (olaparib; AstraZeneca and Merck) tablets for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.

This expanded approval marks Lynparza as the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer as well as the first treatment ever for metastatic breast cancer with a BRCA gene mutation. Concurrently, the FDA also expanded the marketing clearance to the companion diagnostic test, BRCAnalysis CDx (Myriad Genetic Laboratories), to help identify patients eligible for treatment with Lynparza. 

Lynparza was evaluated in OlympiAD, an open-label, multicenter, randomized trial (N=302) of patients with HER2-negative metastatic breast cancer with a germline BRCA mutation who received either Lynparza or physician's choice of chemotherapy (capecitabine, vinorelbine, or eribulin). Patients treated with Lynparza demonstrated a median progression-free survival of 7 months vs 4.2 months in patients treated with chemotherapy alone (hazard ratio [HR] 0.58, 95% CI: 0.43, 0.80; P=0.0009).

Lynparza was initially approved by the FDA to treat patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy. It was co-developed – and will be co-commercialized – by AstraZeneca and Merck, and is available as 100mg and 150mg strength tablets. 

For more information call (800) 237-8898 or visit FDA.gov.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs