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GEN News Highlights : Jan 31, 2012

Pfizer’s Inlyta Approved in U.S. as Therapy for Advanced Renal Cell Carcinoma

Kinase inhibitor cleared for treating RCC after failure of one prior systemic therapy.

FDA cleared Prizer’s kinase inhibitor Inlyta® (axitinib), for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. The approval is based on data from the Phase III Axis study, which showed that in comparison with sorafenib therapy, treatment using Inlyta extended progression-free survival by 43%, from 4.7 months to 6.7 months.

“Inlyta is the first targeted therapy to be approved in the U.S. for patients with advanced RCC after failure of one prior systemic therapy, based on data demonstrating superior progression-free survival when compared to another FDA-approved, targeted agent,” comments Mace Rothenberg, M.D., svp of clinical development and medical affairs at Pfizer’s oncology business unit.

Inlyta is designed an oral therapy designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. The drug is separately being evaluyated in patients with treatment-naïve as well as previously treated advanced RCC, and is undergoing a randomized Phase II clinical trial as a treatment for hepatocellular carcinoma. Pfizer and SFJ Pharma in addition have a development agreement in place under which SFJ will carry out an Asian Phase III clinical trial evaluating axitinib as a adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy.