AVEO Pharmaceuticals, Inc. (AVEO - Snapshot Report) and Astellas Pharma, Inc. (ALPMY) recently announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review tivozanib on May 2, 2013.
A New Drug Application (NDA) for tivozanib seeking approval for the treatment of patients with advanced renal cell carcinoma (RCC) was submitted in Sep 2012. The FDA accepted the application in Nov 2012 with a response expected by Jul 28, 2013.
In Feb 2013, final overall survival (OS) results were announced from the phase III TIVO-1(TIvozanib Versus sOrafenib in 1st line advanced RCC) study.
We note that earlier, the companies had presented results showing that the candidate achieved a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to Nexavar.
According to Cancer Research UK, advanced RCC is estimated to affect more than 250,000 people globally.
We note that tivozanib is currently in additional programs and studies like BATON and TAURUS. The BATON (Biomarker Assessment of Tivozanib in ONcology) program includes studies assessing tivozanib biomarkers in solid tumors. The TAURUS (TivozAnib Use veRsUs Sutent in advanced RCC: Patient Preference) study is being conducted to demonstrate patient preference of tivozanib compared to Sutent (sunitinib) in the first-line treatment of advanced RCC.
We expect investor focus to remain on the outcome of the FDA advisory panel meeting.
While AVEO carries a Zacks Rank #3 (Hold), Astellas carries a Zacks Rank #4 (Sell). Currently, Lannett Company, Inc. (LCI - Snapshot Report) and SIGA Technologies, Inc. look more attractive with a Zacks Rank #1 (Strong Buy).