EMA accepts for review the MAA for niraparib, for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer- Tesaro Inc.

Tesaro Inc. announced that the Marketing Authorisation Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy. With this acceptance, the review of the niraparib marketing authorisation application in the Centralised Procedure will now begin.

The niraparib MAA is supported by data from the ENGOT-OV16/NOVA trial, which is a double-blind, placebo-controlled, international Phase III study of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. The full results of the NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published at the same time in The New England Journal of Medicine.

Comment: Tesaro filed a rolling submission at the FDA in September 2016. AstraZeneca has the only currently marketed PARP inhibitor, Lynparza (olaparib), which is approved to treat ovarian cancer. Notable drugs in the PARP inhibitor pipeline include Clovis Oncology's rucaparib (filed at FDA for ovarian cancer), and AbbVie's veliparib (multiple Phase II studies for oncology indications). Recently Pfizer acquired Medivation and that step included talazoparib (in Phase II trials for ovarian cancer), a former BioMarin drug.