The US Food & Drug Administration today gave market approval to axitinib tablets (Inlyta) for the treatment of patients with previously treated renal cell carcinoma (RCC).
Approval was granted based on a single, international, randomized, open-label trial involving patients with advanced RCC following one prior treatment regimen. Those involved in the trial had received one of the following treatments: sunitinib, temsirolimus, bevacizumab or cytokines.
The trial evaluated 723 patients randomly assigned to receive Inlyta 5 mg twice per day or sorafenib 400 mg twice per day. The former group experienced a 43% improvement in median progression free survival compared to the latter group.
Made by Pfizer, Inlyta is an orally administered kinase inhibitor.
See the FDA's new prescribing data for Inlyta.
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