EMA accepts Pfizer's filing of axitinib for regulatory review to treat advanced renal cell carcinoma

Pfizer Inc. announced today that the European Medicines Agency (EMA) has accepted Pfizer's filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. This submission was based on Phase 3 data from the AXIS 1032 trial. Pfizer will present full results from this trial, as well as additional data on axitinib, at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago from June 3-7, 2011.

"While the prognosis for patients with advanced RCC has improved dramatically over the past five years thanks to the availability of new treatments, there is still a need for new options in this patient population," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "This regulatory filing for our innovative investigational therapy axitinib, as well as ongoing studies of our existing medications, underscores Pfizer's commitment to patients with advanced RCC and our leadership in helping physicians treat this disease."