NEW YORK (AP) — Aveo Pharmaceuticals Inc. said Friday it filed for marketing approval of its drug tivozanib as a treatment for advanced renal cell carcinoma, the most common type of kidney cancer.
Aveo and its partner Astellas Pharma Inc. said they have asked the Food and Drug Administration to clear tivozanib, a tablet designed to be taken once a day. The companies are also studying it as a treatment for several other types of cancer.
Aveo and Astellas have said patients who were treated with tivozanib in two late-stage clinical trials lived longer before death or the resumption disease progression than patients treated with Nexavar, a drug marketed by Onyx Pharmaceuticals Inc. and Bayer HealthCare. However, Aveo said in August that patients in one of the trials were less likely to survive for a year if they were treated with tivozanib: in that trial, 77 percent of tivozanib patients were still alive a year after the start of treatment compared to 81 percent of Nexavar patients.
The company said the FDA was concerned about the data and that it might have to delay is marketing application for a few months as it discussed the issue with the FDA. Analysts said Aveo argued that the Nexavar patients lived longer than the tivozanib patients because of other treatments they received after the trial ended.
Shares of Aveo Pharmaceuticals lost 15 cents to $10.37 in afternoon trading.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration