Zejula sNDA submitted to FDA for ovarian, fallopian tube, or primary peritoneal cancer – Tesaro

Tesaro has submitted a supplemental New Drug Application (sNDA) to the FDA for Zejula (niraparib). The application was granted priority review and has an action date of 24 October 2019. 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 BRCA mutation or Homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy.

The niraparib sNDA is supported by data from QUADRA, a multicentre, open-label, single-arm, phase II trial. Data from the QUADRA trial were recently published in Lancet Oncology. See: “Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase II trial” Kathleen N Moore et al. The Lancet Oncology Volume 20, ISSUE 5, P636-648, May 01, 2019 DOI:https://doi.org/10.1016/S1470-2045(19)30029-4