Trade Resources Industry Views The European Commission Will Review CHMP's Positive Opinion

The European Commission Will Review CHMP's Positive Opinion

Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency for the marketing authorization of axitinib to treat patients with advanced renal cell carcinoma.

The European Commission, which has the authority to approve medicines for the EU, will review CHMP's positive opinion.

Pfizer Oncology Business Unit clinical development and medical affairs senior vice president Mace Rothenberg said that CHMP has adopted a positive opinion for axitinib as a second-line treatment for advanced renal cell carcinoma.

"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," Rothenberg added.

The oral therapy was designed to selectively inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which can influence tumor growth, vascular angiogenesis, and progression of cancer.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/pfizer-renal-cell-carcinoma-therapy-receives-positive-opinion-from-chmp-280512
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Pfizer Renal Cell Carcinoma Therapy Receives Positive Opinion From CHMP