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.
- 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).
- 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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