The U.S. Food and Drug Administration accepted and granted priority review to AstraZeneca PLC's Lynparza tablets in patients with a type of metastatic breast cancer.
A Prescription Drug User Fee Act date is set for the first quarter of 2018.
This is the first submission for a poly ADP-ribose polymerase, or PARP, inhibitor outside ovarian cancer and the third indication submission for Lynparza in the U.S.
The supplemental new drug application to the FDA is based on positive results from the phase 3 OlympiAD trial in patients with germline BRCA-mutated HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.
The drug was first approved in December 2014 for ovarian cancer.
AstraZeneca is developing Lynparza in collaboration with Merck & Co. Inc.
Lynparza tablets are being tested in a range of tumor types including breast, prostate and pancreatic cancers.