FDA Approves Olaparib for Germline BRCA-mutated Metastatic Breast Cancer

On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, 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 is the first FDA-approved treatment for patients with gBRCAm HER2-negative metastatic breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Read the FDA announcement.

Posted 1/12/2018