The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Tesaro’s marketing authorization application for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response or partial response to platinum-based chemotherapy. This opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union. Pending the decision by the EC, Zejula would be the first oral, once-daily poly (ADP-ribose) polymerase 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
Urologic oncologist Wayne Brisbane thought his patient might be a good candidate for focal therapy.
