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ARTICLE | Company News

Aveo receives complete response for RCC therapy

June 11, 2013 1:36 AM UTC

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) received a complete response letter for an NDA for tivozanib to treat advanced renal cell carcinoma (RCC). According to Aveo, FDA said inconsistent progression-free survival (PFS) and overall survival (OS) results and imbalance in post-study treatments make the single open-label Phase III TIVO-1 data "uninterpretable and inconclusive when making a risk-benefit assessment" for the compound's approval. The agency recommended Aveo conduct an additional clinical trial. The company declined to disclose additional details of the FDA's request but will hold an investor conference call on Tuesday. Aveo was up $0.19 to $2.53 on Monday. ...