FDA Approves Olaparib for Breast Cancer With a BRCA Gene Mutation

The FDA has approved the first treatment for breast cancer with a BRCA gene mutation.

The approval expands the use of AstraZeneca’s olaparib (Lynparza) to include the treatment of patients with BRCA-mutated HER2-negative metastatic breast cancer, making it the first PARP inhibitor approved to treat breast cancer, according to the FDA.

“This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer,” said Dave Fredrickson, executive vice president, head of the oncology business unit, AstraZaneca, in a statement. “This is significant for breast cancer patients, as the identification of the BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”

The approval was based on results from the randomized, open-label, phase 3 OlympiAD trial, which compared olaparib versus physician’s choice of chemotherapy. Olaparib significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression by 42%. Patients taking olaparib had a 52% objective response rate compared with 23% for patients receiving chemotherapy, and a confirmed complete response rate of 7.8% compared with 1.5% for patients receiving chemotherapy.

The FDA also expanded the approval of Myriad’s BRCAnalysis CDx, a companion diagnostic to olaparib, to include the detection of BRCA mutations in blood samples from patients with breast cancer.

“This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA approved test to help ensure that they will receive the best available therapy,” said Jonathan Lancaster, MD, PhD, chief medical officer, Myriad Genetics, in a statement.