FDA Advisory Committee recommends Inlyta (Pfizer) for Renal Cell Carcinoma

The FDA Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational agent Inlyta (axitinib), the vascular endothelial growth factor (VEGF) receptor inhibitor from Pfizer, support a favorable benefit/risk profile for the treatment of patients with advanced Renal Cell Carcinoma (RCC) after failure of a first-line systemic therapy. The ODAC panel members reviewed data on Inlyta, including results from the Phase III AXIS trial of patients whose disease had progressed following treatment with one systemic therapy. Inylta has been widely studied in a broad clinical development program, evaluating its efficacy and safety in more than 2,500 patients across several tumor types. Inylta is also being investigated in a randomized Phase III clinical trial in patients with treatment-na�ve as well as previously treated advanced RCC, and in a randomized Phase II clinical trial for the treatment of hepatocellular carcinoma.