Axitinib (Inlyta)

Axitinib, trade name Inlyta, a tyrosine kinase inhibitor, was approved, by the FDA, for the treatment of metastatic kidney cancer patients after failure of a prior treatment. Approval was granted on January 27, 2012 based on the results of the Phase III AXIS trial comparing axitinib’s superior performance over sorafenib (Nexavar) with respect to progression-free survival. Axitinib was also approved by the European counterpart to the U.S. FDA, the European Medicines Agency (EMA), on September 13, 2012, based on the same trial.

We are presenting our review of this trial, the results of which were presented at the ASCO 2011 General Meeting by Dr. Brian Rini of the Cleveland Clinic. We also include a review of the survival analysis for axitinib that was presented at the same conference by Dr. Robert Motzer of Memorial Sloan-Kettering.