Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) regarding the marketing authorization of Axitinib in the European Union (EU), for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

Axitinib, a kinase inhibitor, is an oral therapy that was designed to selectively inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which are receptors that can influence tumour growth, vascular angiogenesis, and progression of cancer.

The CHMP's positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the EU. Pfizer anticipates a decision from the Commission in the coming months.

“Pfizer is very pleased that the CHMP has adopted a positive opinion for axitinib as a second-line treatment for advanced renal cell carcinoma, and we look forward to the decision of the European Commission,” said Mace Rothenberg, MD, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “Despite recent advances in the treatment of advanced kidney cancer, there is a clear need for additional treatment options for patients whose disease has progressed following first-line medications.”

Axitinib is an investigational agent, and has not been approved in the European Union. In January, axitinib was approved by the US Food and Drug Administration (FDA) as INLYTA.


SUTENT is approved for gastrointestinal stromal tumours (GIST) after disease progression on or intolerance to imatinib mesylate, for advanced RCC, and for progressive, well-differentiated pancreatic neuroendocrine tumours (NET) in patients with unresectable locally advanced or metastatic disease.

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.