AVEO Pharmaceuticals Inc.
) and partner
Astellas Pharma, Inc.
) recently received disappointing news from the US Food and Drug
Administration (FDA) as its Oncologic Drugs Advisory Committee
(ODAC) voted against the approval of their oncology candidate,
tivozanib. The news adversely impacted AVEO's stock price.
The ODAC mentioned that tivozanib was unable to demonstrate a
favorable benefit-to-risk evaluation for the treatment of
patients suffering from advanced renal cell carcinoma (RCC).
We note that the ODAC gives independent expert advice and
recommendations to the US regulatory body and the FDA is not
bound to follow its recommendation but it generally does so.
A New Drug Application (NDA) for tivozanib seeking approval
for the treatment of patients with advanced RCC was submitted in
Sep 2012. The FDA accepted the application in Nov 2012 with a
response expected by Jul 28, 2013.
The FDA's advisory body reviewed findings from 17 studies
(n>1,000) including the phase III TIVO-1 (TIvozanib Versus
SOrafenib in 1st line Advanced RCC) study. In the TIVO-1 study,
tivozanib achieved a statistically significant improvement in the
primary endpoint of progression-free survival (PFS) compared to
We are disappointed by the news. We expect investor focus to
remain on the response from the FDA for tivozanib. However, we
see very low chances of the candidate getting approval at this
Tivozanib is being studied in other additional programs and
studies as well including the BATON and TAURUS studies. The BATON
(Biomarker Assessment of Tivozanib in ONcology) program includes
studies assessing tivozanib biomarkers in solid tumors. TAURUS
(TivozAnib Use veRsUs Sutent in advanced RCC: Patient Preference)
is being conducted to demonstrate patient preference of tivozanib
compared to Sutent (sunitinib) as first-line therapy in patients
with advanced RCC.
Other pipeline candidates at AVEO include oncology candidates
AV-203 and ficlatuzumab.
While AVEO carries a Zacks Rank #2 (Buy), Astellas carries a
Zacks Rank #5 (Strong Sell). Currently,
Cleveland BioLabs Inc.
) look more attractive in the pharma space with a Zacks Rank #1
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