BioCentury
ARTICLE | Clinical News

FDA approves Tesaro's Varubi rolapitant IV to prevent CINV

November 3, 2017 7:00 PM UTC

On Oct. 25, FDA approved a resubmitted NDA for Varubi rolapitant IV from Tesaro Inc. (NASDAQ:TSRO) in combination with other antiemetic agents to prevent delayed chemotherapy-induced nausea and vomiting (CINV). Tesaro expects to launch the drug this month at an expected wholesale acquisition cost (WAC) of $295 per ready-to-use vial.

Earlier this year, Tesaro received a complete response letter from FDA requesting additional information on the in vitro method used to demonstrate comparability of rolapitant IV produced by 2 proposed manufacturers (see BioCentury, Jan. 13)...