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Fotivda FDA Approval History

FDA Approved: Yes (First approved March 10, 2021)
Brand name: Fotivda
Generic name: tivozanib
Dosage form: Capsules
Company: AVEO Oncology
Treatment for: Renal Cell Carcinoma

Fotivda (tivozanib) is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

  • The VEGF pathway plays an important role in cancer angiogenesis and VEGFR-TKIs are an established treatment option for renal cell carcinoma. Tivozanib works as a potent, selective, long half-life inhibitor of all three VEGFRs, and is designed to optimize VEGF blockade efficacy with improved safety and tolerability relative to other VEGFR-TKIs.
  • Fotivda is taken once daily with or without food for 21 days on-treatment followed by 7 days off-treatment (28-day cycle) until disease progression or unacceptable toxicity.
  • Common adverse reactions include fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, stomatitis, and laboratory abnormalities.

Development Timeline for Fotivda

DateArticle
Mar 10, 2021Approval  FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma
Mar 31, 2020AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma
Nov  4, 2019AVEO Oncology Announces Regulatory Update For Tivozanib In Renal Cell Carcinoma
Sep 10, 2019AVEO Oncology Announces Updated Overall Survival Hazard Ratio Of 0.99 In Phase 3 TIVO-3 Trial Of Tivozanib In Renal Cell Carcinoma
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

Further information

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