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.
“Your entire practice, cancer has been associated with an aging population, and then you have a young, beautiful, healthy-looking woman like Alisa Secaida come into your office, it's not a surprise that the doctor, their knee-jerk reaction would be like, ‘Maybe just slow down,’” said The Cancer Letter’s Claire Marie Porter.
