EC Has Granted Marketing Authorization to Pfizer's INLYTA (Axitinib) Oral Therapy

The European Commission (EC) has granted marketing authorization to Pfizer's INLYTA (axitinib) oral therapy, designed to treat adult patients with advanced renal cell carcinoma (RCC).

INLYTA, a kinase inhibitor, is designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3,1a, which are proteins that influence tumor growth, vascular angiogenesis and progression of cancer.

The approval is based on data from the Phase 3 AXIS trial, designed to assess the safety and efficacy of INLYTA.

The results demonstrated that INLYTA significantly extended progression free survival [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.

Pfizer oncology business unit president Andreas Penk said the EC has approved 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," Penk added.

"INLYTA is a valuable addition to Pfizer's portfolio for the treatment of advanced RCC, which includes SUTENT6a and TORISEL® (temsirolimus)7a."