- The approval is based on a P-III TIVO-3 study that involves assessing Fotivda (1.34 mg/qd, with or without food for 21days followed by 7days off treatment) vs sorafenib in 350 patients in a ratio (1:1) with r/r advanced RCC following two or more prior systemic therapies.
- The application is also supported by three additional trials in RCC and includes safety data from 1,000+ trial subjects. The P-III TIVO-3 study results: mPFS (5.6 vs 3.9mos.), m-OS (16.4 vs 19.2mos.), ORR (18% vs 8%).
- Fotivda (tivozanib, qd, PO) is a VEGF tyrosine kinase inhibitor and is available to patients in the US by Mar 31, 2021
Click here to read full press release/ article | Ref: Business Wire | Image: AVEO Oncology