FDA Recommends No NDA for Tivozanib in RCC

January 31, 2019 – The FDA has recommended that Aveo Oncology should not submit a new drug application (NDA) for tivozanib with the preliminary overall survival (OS) data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma (RCC). The agency indicated that the preliminary findings do not alleviate their concerns regarding a potential detriment in OS, which were outlined in a complete response letter … (leggi tutto)