US FDA accepts Pfizer NDA for kidney cancer drug axitinib

The US Food and Drug Administration has accepted global drugs behemoth Pfizer’s (NYSE: PFE) filing for standard review of axitinib for patients with advanced renal cell carcinoma (RCC), the company said yesterday. Pfizer filed for European approval of the drug earlier this month (The Pharma Letter June 2).

The US submission was based on Phase III data from the AXIS 1032 trial, comparing axitinib with sorafenib (which Germany’s Bayer markets under the trade name Nexavar) in patients with previously treated advanced RCC that Pfizer recently presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). He study showed that Pfizer's drug extended progression-free survival by 6.7 months, compared with 4.7 months for sorafenib.

“This filing represents a significant step towards accomplishing Pfizer’s goal of bringing axitinib to advanced RCC patients who are in need of additional, effective treatment options,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. “Pfizer Oncology's commitment to provide new medicines for renal cell carcinoma patients is one of our top priorities. We are excited about the benefits which axitinib has demonstrated in clinical development and, subject to FDA review, its potential to improve the lives of patients,” he added.