(By Balaseshan) Pfizer Inc. (NYSE:PFE), a research-based, global biopharmaceutical company, said it has received marketing authorization for kidney cancer therapy in Europe.
The European Commission (EC) has granted marketing authorization for Inlyta (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine.
The approval is based on data from the Phase 3 AXIS trial, which demonstrated that Inlyta significantly extended progression free survival (PFS) with a median PFS of 6.8 months compared with 4.7 months for those treated with sorafenib, a current second-line standard of care for this patient population, representing a 45% improvement in median PFS compared to sorafenib.
"We are delighted with the decision of the European Commission to approve Inlyta for adult advanced RCC patients whose disease has progressed following failure of Sutent or a cytokine. Pfizer Oncology recognizes advanced RCC is a complex disease and we are committed to bringing new targeted medicines to physicians and their patients," said Andreas Penk, Regional President of Europe for the Pfizer Oncology Business Unit.
Inlyta, a kinase inhibitor, is an oral therapy that was designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which are proteins that can influence tumor growth, vascular angiogenesis and progression of cancer (tumor spread).
In January 2012, Inlyta was approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. Inlyta has also been approved in a number of other countries, including Switzerland, Japan, Canada, Australia, and Korea.
PFE closed Friday's regular session up 0.08% at $23.86. The stock has been trading between $17.05 and $24.49 for the past 52 weeks.