FDA accepts Pfizer's filing for axitinib review for advanced renal cell carcinoma

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Pfizer's filing for standard review of axitinib for patients with advanced renal cell carcinoma (RCC). This submission was based on Phase 3 data from the AXIS 1032 trial, comparing axitinib with sorafenib in patients with previously treated advanced RCC, which Pfizer recently presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO).

“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”

"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."

Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC, the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20 percent.

Source Pfizer Oncology