Shots:

• 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

  Ref: Business Wire | Image: AVEO Oncology