Biocentury: AVEO’s FDA Woes for Renal Cell Carcinoma Drug stops Astella’s Funding

AVEO Pharmaceuticals’ (AVEO) New Drug Application (NDA) with the FDA for their newly developed once a day oral medication to fight advanced renal cell carcinoma –  known as Tivozanib – has hit a snag. The drug is an oral quinoline urea derivative that suppresses angiogenesis by being selectively inhibitory against vascular endothelial growth factor. Upon review, the  FDA’s Oncologic Drugs Advisory Committee voted 13-1 against approval due to safety concerns. Since the release of the FDA Advisory Committee vote, AVEO’s partner, Astellas, has pulled funding. Based on previous studies, Aveo’s candidate did demonstrate potential to serve as an improved medication from current standard of care. Phase III results on advanced renal cell carcinoma suggested a 30% or 3 months improvement in median PFS compared to sorafenib, approved for the treatment of primary kidney cancer and advanced primary liver cancer, and co-marketed by Bayer and Onyx Pharmaceuticals. Following the vote, AVEO  the company “is currently evaluating the effect of Astellas’ decision on the clinical and regulatory path forward for Tivozanib in RCC.” Until then, the company will wait for the FDA’s formal decision (PDUFA date July 28th), which at this point seems to be a rejection.

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