AVEO Pharmaceuticals, Inc.
Astellas Pharma, Inc.
) recently received a complete response letter (CRL) for
tivozanib from the US Food and Drug Administration (FDA).
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 informed AVEO that the
NDA is not approvable in its present form.
According to the CRL, the TIVO-1 results were not
interpretable and conclusive enough to support a risk-benefit
assessment, essential for approval. The inconsistent
progression-free survival (PFS) and overall survival (OS) results
and also an imbalance in post-study treatments made the TIVO-1
results non conclusive. AVEO will need to conduct an additional
study to gain approval. Additionally, the FDA has asked the
companies to update and resubmit the proposed dissolution
acceptance criterion as it was not supported by appropriate
The CRL did not come as a surprise as the FDA's Oncologic
Drugs Advisory Committee (ODAC) had reviewed tivozanib on May 2,
2013 and mentioned that tivozanib did not show a favorable
benefit-to-risk evaluation for the treatment of advanced RCC in
an adequate and well-controlled study.
Partner, Astellas, has decided that it will not fund the
development of tivozanib for advanced RCC in the US. Moreover,
Astellas does not intend to file for approval in Europe for this
indication. However, AVEO and Astellas said that they will
continue studying tivozanib for colorectal and breast cancer.
Conducting additional trials would be costly for AVEO alone
and it might take roughly five years for the candidate to get
approved, if at all. As a result, AVEO has decided to discontinue
tivozanib in advanced RCC. The company also announced a
restructuring program under which 62% of the work force will be
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 in the first-line treatment of advanced RCC.
While AVEO carries a Zacks Rank #2 (Buy), Astellas carries a
Zacks Rank #3 (Hold). Currently,
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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