FDA advisory votes against AVEO and Astellas' cancer drug tivozanib

US biotech firm AVEO Oncology (Nasdaq: AVEO) saw its shares plunge as much as 57% in late trading yesterday (May 2), after the stock was suspended ahead of a Food and Drug Administration advisory panel which, at the end of the day, gave a negative opinion for the company’s cancer drug tivozanib. The stock closed down 49.6% at $2.65.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib, partnered with Japanese drug major Astellas (TYO: 4503), did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC; kidney cancer) in an adequate and well-controlled trial (13 to one with no abstentions).

It was noted that while the drug conferred a 20% benefit in delaying disease progression, it increased the risk of death by 25%. Panelists also expressed concern that most of the patients in the late-stage TIVO-1 trial were studied in Central and Eastern Europe and they questioned whether the results would be applicable to the US population.