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Tivozanib Recommended for EU Approval for RCC

Jason Harris
Published: Friday, Jun 23, 2017

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The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of tivozanib (Fotivda) for adult patients with advanced renal cell carcinoma (RCC).

In May of that year, the FDA’s Oncologic Drugs Advisory Committee voted 13-1 against tivozanib. The committee said that there are a number of drugs available to treat advanced RCC and tivozanib did not demonstrate superiority over the existing options.

References

  1. 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. 31, 2012 (suppl; abstr 4501).
  2. 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. 31, 2013 (suppl 6; abstr 350).

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