Aveo Oncology of Cambridge and Astellas Pharma Global Development Inc. said today a U.S. Food and Drug Administration advisory committee will review the company's advanced renal cell carcinoma treatment.
The review of tivozanib will take place on May 2. The FDA's Oncologic Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the commissioner of food and drugs.
The review of Aveo's new drug application for tivozanib is expected to be complete by July 28, officials said. Aveo's partner is a U.S. subsidiary of Tokyo-based Astellas Pharma Inc.
Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a third clinical study in advanced renal cell carcinoma have been reported, the company said, adding the drug is being evaluated in other tumors.
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