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FDA Recommends No NDA for Tivozanib in RCC

Gina Columbus @ginacolumbusonc
Published: Thursday, Jan 31, 2019

Michael Bailey

Michael Bailey

The FDA has recommended that Aveo Oncology should not submit a new drug application (NDA) for tivozanib (Fotivda) with the preliminary overall survival (OS) data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma (RCC).1

However, in June 2013, the FDA rejected an application for tivozanib in RCC after concluding that the TIVO-1 findings demonstrated inconsistent PFS and OS data, adding that there was also an imbalance in poststudy treatments used; this made the findings and the efficacy of tivozanib compared with existing therapies difficult to interpret. Additionally, the FDA found the risk-benefit assessment inconclusive. This rejection followed the FDA’s Oncology Drugs Advisory Committee recommendation, which voted 13 to 1 against approving tivozanib.

References

  1. AVEO Oncology Announces NDA Timing Update. Aveo Oncology. Published January 31, 2019. https://bit.ly/2WAkAtd. Accessed January 31, 2019.
  2. AVEO Oncology Announces Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma Meets Primary Endpoint. Posted November 6, 2018. https://bit.ly/2OrdaDy. Accessed November 6, 2018.
  3. Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: Results from a phase III randomized, open label, multicenter trial. J Clin Oncol. 2012;31(suppl; abstr 4501). doi: 10.1200/jco.2012.30.15_suppl.4501.
  4. Motzer RJ, Eisen T, Hutson TE, et al. Overall survival in patients from a phase III study of tivozanib hydrochloride versus sorafenib in patients with renal cell carcinoma. J Clin Oncol. 2013;31(suppl 6; abstr 350). doi: 10.1200/jco.2013.31.6_suppl.350.

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