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Tivozanib Approval Status

  • FDA approved: No
  • Generic name: tivozanib
  • Company: AVEO Oncology and Astellas Pharma Inc.
  • Treatment for: Renal Cell Carcinoma

Tivozanib is an investigational tyrosine kinase inhibitor for the treatment of advanced renal cell carcinoma.

In June 2013, AVEO Oncology announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tivozanib had not been approved.

Development Status and FDA Approval Process for tivozanib

Feb 15, 2014AVEO and Astellas to End Worldwide Collaboration & License Agreement for Tivozanib
Dec 16, 2013AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal Cancer
Jun 10, 2013AVEO Announces Complete Response Letter Received for Tivozanib New Drug Application in Renal Cell Carcinoma
May  2, 2013AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk Evaluation in Treatment of Advanced Renal Cell Carcinoma
Feb 27, 2013AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
Nov 28, 2012AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
Sep 28, 2012AVEO and Astellas Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

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