BRIEF—FDA accepts Zejula sNDA for priority review

A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration for Zejula (niraparib) by GlaxoSmithKline.

The application was granted priority review and has an action date of October 24, 2019.

The drug was acquired by GSK along with its buy of US drugmaker Tesaro for $5.1 billion.

The sNDA supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either:

The niraparib sNDA is supported by data from the QUADRA trial, which were recently published in Lancet Oncology.