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FDA Okays AVEO's NDA Filing for Treating Renal Cell Carcinoma

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AVEO Pharmaceuticals, Inc. AVEO announced that the FDA has accepted its filing of a new drug application (NDA) seeking approval for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC). The regulatory agency officials also mentioned that they do not currently plan to convene an Oncologic Drug Advisory Committee (ODAC) meeting to discuss the application.

The regulatory body has set a Prescription Drug User Fee Act target action date of Mar 31, 2021.

In March 2020, AVEO submitted the NDA for tivozanib to the FDA for the treatment of relapsed or refractory RCC.

The NDA was based on data from the phase III TIVO-3 study, which evaluated tivozanib for the third and fourth-line RCC. Per the company, the application is also supported by three additional studies including the active comparator-controlled phase III TIVO-1 study comparing tivozanib to Bayer AG’s BAYRY Nexavar (sorafenib) for first-line RCC, and two phase II clinical studies on tivozanib for patients who progressed on Nexavar in TIVO-1 and the placebo-controlled one for first-line RCC.

Shares of AVEO have rallied 22.8% so far this year compared with the industry’s increase of 9%.

We remind investors that in August 2017, AVEO and partner EUSA Pharma received an approval from the European Commission for its VEGF tyrosine kinase inhibitor Fotivda (tivozanib) to treat advanced RCC. AVEO receives royalties from Fotivda sales in certain European countries and additional milestone fees on the reimbursement approval obtained by EUSA.

Meanwhile, AVEO is evaluating Fotivda in combination with AstraZeneca’s AZN PD-L1 inhibitor Imfinzi (durvalumab) in the phase Ib/II DEDUCTIVE study for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma with no history of systemic therapy.

AVEO is also evaluating Fotivda in combination with Bristol-Myers’ BMY PD-1 inhibitor Opdivo (nivolumab) in the Ib/II TiNivo study for first- and second-line treatment of RCC.

A potential approval of the drug in the United States, will boost its sales in the days ahead.

Zacks Rank

AVEO currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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