Posted by Michael Wonder on 16 Sep 2017
Tesaro receives positive CHMP opinion for Zejula
15 September 2017 - Tesaro today announced that the EMA CHMP has issued a positive opinion for the Company's marketing authorisation 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 (CR) or partial response (PR) to platinum-based chemotherapy.
This opinion will now be referred to the European Commission, which grants marketing authorisation for medicines in the European Union. Pending the decision by the EC, Zejula would be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
Zejula was approved by the FDA on 27 March 2017 and is marketed by Tesaro in the United States, where it is the most frequently prescribed PARP inhibitor.
