TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA

WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today 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...

London, 27/10/2016 (informazione.it - comunicati stampa - servizi)

WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today 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.