Aveo plunges as FDA recommends against cancer drug

Aveo shares tumble after FDA panel recommends against Tivopath as a kidney cancer treatment

Associated Press

NEW YORK (AP) -- Shares of Aveo Pharmaceuticals plunged almost 50 percent Thursday after the company said a Food and Drug Administration panel recommended its drug Tivopath not be approved as a treatment for advanced kidney cancer.

Aveo Oncology and its partner Astellas Pharma of Japan said the panel voted 13-to-1 that the benefits of the once-per-day pill did not justify the risks it poses to patients. The companies are seeking approval to market the drug as a treatment for advanced renal cell carcinoma, the most common type of kidney cancer.

The FDA is scheduled to make a decision on Tivopath, or tivozanib, by July 28. The agency is not required to follow the advice of its panels, but it often does.

Shares of Aveo fell $2.61, or 49.6 percent, to close at $2.65. Earlier the stock reached an all-time low of $2.25.

The companies say that patients who were treated with tivozanib in two late-stage clinical trials lived longer before death or the resumption of disease progression than patients treated with Nexavar, a drug marketed by Onyx Pharmaceuticals Inc. and Bayer HealthCare. However in one of the trials, patients who took Tivopath were less likely to be alive a year after the start of treatment.

According to analysts Aveo said the Nexavar patients lived longer because of other treatments they received after the trial ended.

The companies said patients treated with Tivopath were less likely to experience side effects than patients on Nexavar, and they were less likely to reduce their doses or stop taking the drug temporarily or permanently. However severe high blood pressure was more common in Tivopath patients.

The companies are also studying Tivopath as a treatment for other types of solid tumors, including cancers of the breast and colon.

Aveo's legal name is Aveo Pharmaceuticals Inc. In 2012 the company renamed itself Aveo Oncology as part of a rebranding effort.

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