EC grants marketing authorization for Pfizer’s INLYTA to treat renal cell carcinoma

Sep 4 2012

Pfizer Inc. announced today that 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.    

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).

"INLYTA offers physicians and their patients with advanced kidney cancer a new treatment option following prior treatment with sunitinib or a cytokine. INLYTA data demonstrate statistically significant improvement in progression free survival compared with sorafenib, and support the continued role for VEGFR-targeted therapy, following the first-line standard of care, SUTENT," said Dr. Bernard Escudier, Head of the Immunotherapy Unit, Department of Medical Oncology, Institut Gustave Roussy, France, who served as an investigator on this Pfizer-sponsored study and is a paid consultant to Pfizer Oncology.  

The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free survival (PFS) [HR=0.67, 0.56-0.81, P<0.0001] with a median PFS of 6.8 months (95% CI: 6.4, 8.3) compared with 4.7 months (95% CI: 4.6, 6.3) for those treated with sorafenib, a current second-line standard of care for this patient population, representing a 45 percent improvement in median PFS compared to sorafenib. Renal cell carcinoma is the sixth leading cause of cancer-related death. At diagnosis, approximately a third of kidney cancer patients will have advanced disease, where the cancer has spread to multiple parts of the body and prognosis is poor. The incidence of RCC in Europe is 102,000 people per year. Between 40 and 65 percent of patients worldwide who progress following first-line therapy go on to receive a second-line treatment.   

"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 Dr. Andreas Penk, Regional President of Europe for the Pfizer Oncology Business Unit. "INLYTA is a valuable addition to Pfizer's portfolio for the treatment of advanced RCC, which includes SUTENT and TORISEL^® (temsirolimus)."