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FDA Approves AVEO Oncology's Fotivda For Renal Cell Carcinoma

Shares of AVEO Oncology (AVEO) jumped about 20% in extended trading hours Wednesday after the company announced that the FDA approved Fotivda (tivozanib) for the treatment of patients with relapsed or refractory advanced renal cell carcinoma.

Fotivda is the first therapy approved for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. The company plans to make the treatment available to patients in the U.S. by March 31, 2021.

Fotivda is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

The approval of Fotivda was based on AVEO's pivotal Phase 3 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.

AVEO closed Wednesday's trading at $15.28, up $7.20 or 89.11%, on the Nasdaq. The stock further gained $3.08 or 20.16% in the after-hours trade.

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