Long-awaited FDA approval for AVEO Oncology's Fotivda

11 March 2021

After several US setbacks affecting the firm’s lead product, AVEO Oncology (Nasdaq: AVEO) late Wednesday finally received US Food and Drug Administration approval for Fotivda (tivozanib) as a treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies.

News of the approval sent AVEO’s shares shooting up 89% to $15.28 by close of trading yesterday, and a further 6.3% to $16.24 pre-market today.

The approval of Fotivda is based on AVEO’s pivotal Phase III study, TIVO-3, comparing Fotivda to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.

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