Posted by Michael Wonder on 25 Jun 2019
U.S. FDA accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review
24 June 2019 - GlaxoSmithKline plc today announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental new drug application to the U.S. FDA for Zejula (niraparib).
The application was granted priority review and has an action date of 24 October 2019.
The application 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:
- BRCA mutation or
- Homologous recombination deficiency and have progressed more than six months after the last platinum-based chemotherapy.
