Aveo Oncology gets the long-awaited greenlight to market tivozanib — 9 years after filing its first NDA
Seven years after Aveo Oncology’s tivozanib was subjected to a scathing dressdown by the FDA’s cancer czar Richard Pazdur — followed by a swift rejection and a bumping road toward refiling — the tyrosine kinase inhibitor has been approved for relapsed or refractory advanced renal cell carcinoma. Known for over a decade as tivo, the drug will now be marketed as Fotivda.
It was a much narrower label than what they had initially sought, but the approval marked the best news the Boston biotech has put out in years. Share shot up 89.11% to $15.28 soon after the announcement hit the wires, and then some more in after-market trading.
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