AVEO Oncology and Astellas Pharma have announced FDA acceptance of tivozanib new drug application(NDA)filing for the treatment of advanced renal cell carcinoma(RCC).
According to the development and commercialization deal signed between the firms,NDA acceptance by the FDA has triggered a milestone payment worth$15m to AVEO from Astellas.
The efficacy and safety data from the Phase 3 TIvozanib Versus SOrafenib in 1st line Advanced RCC(TIVO-1)trial along with the data from 16 additional studies sponsored by AVEO conducted in more than 1,000 subjects administered with tivozanib are included in the NDA.
Safety and efficacy of the investigational compound Tivozanib with an anticipated brand name of Tivopath,is not completely established so far.
The review of kidney cancer pill that is not approved in any country is likely to be completed by 28 July 2013.