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FDA accepts application for tivozanib in patients with renal cell carcinoma
AVEO Oncology and Astellas Pharma Inc. recently announced that the FDA has accepted for filing the new drug application for tivozanib, with the projected indication for the treatment of patients with advanced renal cell carcinoma.
Tivozanib is an oral, once daily, investigational tyrosine kinase inhibitor of all three VEGF receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities.
The new drug application includes results of the global phase 3 TIVO-1 trial, a randomized superiority-designed pivotal trial that evaluated the efficacy and safety of tivozanib vs. sorafenib (Nexavar; Bayer and Onyx) in 517 patients with advanced renal cell carcinoma. The trial also included data from 16 supplementary AVEO-sponsored studies involving more than 1,000 patients who received tivozanib.
“TIVO-1 is novel in that this phase 3 clinical study used an approved targeted comparator drug to evaluate first-line [renal cell carcinoma] treatment,” Robert J. Motzer, MD, of the genitourinary oncology service at Memorial Sloan-Kettering Cancer Center, said in a press release. “Patients in the study who had no prior treatment for advanced kidney cancer and who were given tivozanib met the primary PFS endpoint and tolerated the drug well.”
Currently, tivozanib is an investigational medicine and is not approved in any country. According to the timelines established by the Prescription Drug User Fee Act, the review of the new drug application is expected to be complete by July 28, 2013.