Olaparib becomes the first drug approved for BRCA breast cancer


The FDA has expanded the label for AstraZeneca’s oral PARP inhibitor Lynparza (olaparib) to include the treatment of patients with metastatic breast cancer whose disease is associated with a BRCA gene mutation.

The decision makes olaparib the first and only approval for a PARP inhibitor for use beyond ovarian cancer. It is the first time any drug has been approved specifically to treat BRCA-mutated breast cancer.

The approval is a result of the highly promising results published from the Phase III OLYMPIAD trial, which demonstrated that olaparib provided a significant benefit over standard therapy, reduced the chance of progression of advanced BRCA-related breast cancer by 42% and delayed progression by 2.8 months. You can find out more about the trial in our 2017 highlights editorial.

Olaparib is already approved in the US for women with BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. It has also been granted approval for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumours have at least partially responded to chemotherapy.

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” Richard Pazdur, from the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented.

Pazdur added that the: “approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

Andrew Tutt, from the Breast Cancer Now Research Centre at The Institute of Cancer Research (UK), was part of the early laboratory research behind PARP inhibitors in patients with BRCA mutations, and led some of the early clinical trials of olaparib. He commented: “We are delighted that the FDA has approved olaparib for advanced breast cancer in women who have inherited BRCA1 or BRCA2 mutations. This is excellent news for women with this uncommon but important genetic form of breast cancer many of whom took part in the clinical trials.”

Sources: First Word Pharma press release; ICR press release