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AVEO Pharmaceuticals, Inc. (AVEO - Snapshot Report) and Astellas Pharma, Inc. (ALPMY) 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 data.

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 eliminated.

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 Pfizer Inc.’s (PFE - Analyst Report) 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, Santarus, Inc. looks more attractive with a Zacks Rank #1 (Strong Buy).

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