Aveo Pharma's Stock Trading Higher On Much Awaited FDA Approval For Tivozanib In Relapsed Kidney Cancer

The FDA has finally approved AVEO Pharmaceuticals Inc’s (NASDAQ: AVEO) tivozanib for advanced renal cell carcinoma, nine years after it first submitted its marketing application to the agency.

• The label covers relapsed or refractory renal cell carcinoma who have received two or more prior systemic therapies.
• Tivozanib, a tyrosine kinase inhibitor, witnessed rejection and a bumpy road toward refiling. The drug will now be marketed as Fotivda.
• The approval has set off a scramble to make the most out of the drug before its U.S. patent expires in 2022. The company said it’s applying for a patent term extension to stretch it out to 2027. See the latest 10K here.

Tivozanib regulatory pathway timeline:

• In September 2012, the company and its then collaborating partner Astellas Pharma Inc (OCTMKT: ALPMF) submitted a marketing application with the FDA.
• In November 2012, the application was accepted for review by the FDA, which was supposed to conclude by July 28, 2013.
• In May 2013, FDA’s Oncologic Drugs Advisory Committee voted against the application and said that tivozanib did not demonstrate a favorable benefit-to-risk evaluation.
• In June 2013, the FDA issued a complete response letter for tivozanib, citing inconsistent progression-free survival and overall survival results and imbalance in post-study treatments.
• In February 2014, Astellas Pharma Inc walked away from the collaboration after an interim analysis of tivozanib in colorectal cancer was unlikely to meet the primary endpoint, and the study was stopped.
• In September 2019, the company reported results from the second prespecified analysis of overall survival in the TIVO-3 trial. Included hazard ratio below 1.00, favoring tivozanib.
• In March 2020, tivozanib application in renal cell carcinoma was resubmitted. The application was mainly on data presented at ASCO involving 350 patients. Aveo said the final hazard ratio was 0.97.
• In June 2020, the application was accepted for review with a target action date of March 31, 2021.
• Price Action: AVEO shares jumped 19.4% at $18.24 in premarket trading on the last check Thursday.