BRIEF—Priority review status for first PARP inhibitor application outside of ovarian cancer

The UK’s AstraZeneca and New Jersey-based Merck & Co have announced the US FDA will review an application to extend the label for Lynparza (olaparib).

The firms joined forces earlier this year to co-develop and commercialize the PARP inhibitor in multiple oncology indications.

The FDA has additionally granted priority review status to the application, which covers germline BRCA-mutated, HER2-negative metastatic breast cancer patients who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.

It is the first submission for a PARP inhibitor outside of ovarian cancer. A decision is expected in the first quarter of next year.