Pfizer files for EU approval of axitinib in advanced kidney cancer

The European Medicines Agency (EMA) has accepted US drugs behemoth Pfizer’s (NYSE: PFE) filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. This is the first regulatory submission for the kidney cancer drug by the company.

This submission was based on Phase III data from the AXIS 1032 trial. Pfizer will present full results from this study, 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. The company said it is working with other regulatory agencies with the objective of gaining approval in other territories for axitinib, which is viewed as one of Pfizer’s leading investigational drug candidates.

“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,” he added.