EMA CHMP adopts positive opinion for Pfizer’s axitinib to treat advanced renal cell carcinoma

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Pfizer announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion 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.

“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, 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 tumor 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."

Source Pfizer

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