Tivozanib is under FDA review, with an approval decision expected by July 28.
To bolster the supportive case for approval, Aveo is also expected to point to other analyses from the phase III trial supporting tivozanib's efficacy in kidney cancer patients. Treatment with tivozanib following Nexavar resulted in a median progression-free survival of 8.4 months and a tumor response rate of 13%. Tivozanib-treated patients reported fewer side effects dose reductions than patients treated with Nexavar, but this did not translate into a significant difference in quality of life scores between the two drugs.
The median overall survival of 28.8 months reported by tivozanib-treated patients is similar to survival rates of competing kidney cancer drugs. In a recent study comparing Glaxo's Votrient to Pfizer's Sutent, median overall survival was 28.4 months and 29.3 months, respectively. Aveo has only compared tivozanib directly against Nexavar but is conducting another study right now that pits tivozanib against Sutent.
Multiple presentations of data from the tivozanib phase III study in kidney cancer are being presented later this week at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
If FDA approves tivoazanib, it will be the ninth drug marketed for kidney cancer and the fifth drug to share a similar mechanism of action. Sutent has been the market-leading kidney cancer drug but has recently lost ground to Votrient.
-- Reported by Adam Feuerstein in Boston.