FDA to Aveo: That's still a 'no' on tivo. Aveo: We'll be back.
In the never-ending but hardly-changing saga of the FDA and Aveo Oncology, the US regulator has once again spurned the company for failing to prove that their drug helped renal cell carcinoma patients live longer.
Aveo announced this morning that the FDA recommended they not submit an NDA application because the latest Phase III trial data don’t allay the agency’s concern that their drug, tivozanib, is hurting patients, as compared with the baseline treatment, Bayer’s sorafenib. Once again, the concern is about the overall survival rate.
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