CHMP recommends Fotivda for RCC

EMA's CHMP recommended approval of Fotivda tivozanib (ASP4130, AV-951) from Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) and EUSA Pharma Ltd. (Hemel Hempstead, U.K.) to treat advanced renal cell carcinoma (RCC). Specifically, the recommendation is for first-line treatment of patients with advanced RCC, and for RCC patients who are VEGF receptor and mammalian target of rapamycin (mTOR; FRAP; RAFT1) pathway inhibitor-naïve following disease progression after 1 prior treatment with cytokine therapy.

EUSA has exclusive rights to develop and commercialize Fotivda in Europe, Latin America, Africa and Australasia to treat cancer, excluding conditions of the eye (see BioCentury, Jan. 11, 2016). If the European Commission approves Fotivda, Aveo would be eligible for up to $16 million in milestones from EUSA. Aveo President and CEO Michael Bailey told BioCentury that he expects EUSA to launch Fotivda "as quickly as possible," if approved...