Pfizer Inc. announced that the US 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,” 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 per cent.

Axitinib is an oral and selective inhibitor of Vascular Endothelial Growth Factor (VEGF) receptors 1, 2 and 3, receptors that can influence tumour growth, vascular angiogenesis and progression of cancer (the spread of tumours). Axitinib is an investigational agent that has not been approved by regulatory agencies in any countries or jurisdictions.

Axitinib is also being investigated in a randomized phase III clinical trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized phase II clinical trial for the treatment of Hepatocellular Carcinoma (HCC).

As a leader in the treatment of advanced RCC, Pfizer Oncology is dedicated to offering multiple treatments and investigating new agents in different populations and stages of disease. Pfizer’s RCC portfolio offers two approved therapies for the treatment of people with advanced RCC. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, licensing partners and people affected, we are committed to advancing the science of RCC through research into established and novel compounds, as well as the exploration of biomarkers to better personalize therapy.

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Pfizer Oncology has biologics and small molecules in clinical development and more than 100 clinical trials underway.