FDA Staff Says AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) Kidney Cancer Drug May Need More Study

Published: May 01, 2013

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Aveo Pharmaceuticals Inc. (AVEO)’s lead product candidate, a kidney cancer drug, may need another clinical trial to assess the benefit, U.S. regulators said. Aveo shares dropped in early trading. While the medicine showed better results than Bayer AG (BAYN) and Onyx Pharmaceuticals Inc. (ONXX)’s Nexavar in delaying disease progression, a trend toward a reduction in patients’ overall survival led Food and Drug Administration staff in a report today to question whether Aveo should conduct further study. A panel of FDA advisers will meet May 2 to discuss the compound, called tivozanib. Aveo applied for FDA approval based on one final-phase trial that primarily studied tivozanib’s effect on the cancer’s progression. If approved, tivozanib may generate sales of $287 million in 2016 for Aveo, according to the average of three analysts’ estimates compiled by Bloomberg.

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