FDA Approves Olaparib for Patients with Metastatic Breast Cancer and BRCA Mutation

By the Editors

The FDA has expanded the approval of olaparib (Lynparza) for patients with metastatic breast cancer who have a germline BRCA genetic mutation.

Olaparib, a PARP (poly ADP-ribose polymerase) inhibitor, was first approved in 2014 to treat advanced ovarian cancer. The new indication is for patients with BRCA mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic cancer who have previously received chemotherapy.

In a trial of 300 patients, median progression-free survival was longer in patients given olaparib versus those given only chemotherapy (7.0 vs. 4.2 months).