AVEO Pharmaceuticals, Inc.
Astellas Pharma, Inc.
) 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,
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
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.
SIGA Technologies, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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