Pfizer Inc., the world's largest drugmaker, has announced that the US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) have voted unanimously 13 to 0 that data for the investigational agent axitinib support a favourable benefit profile for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of a first-line systemic therapy. The ODAC panel’s recommendation will be considered by the FDA when making its decision regarding Pfizer’s NDA for axitinib as a treatment for advanced RCC.
Approximately 58,000 new cases of RCC are diagnosed in the United States each year, and approximately 20 to 30 percent of these patients have advanced disease at the time of diagnosis. Around 13,000 individuals die of this tumour in the US each year.
“We are pleased with the panel’s recommendation in support of axitinib for the treatment of previously treated advanced RCC, as additional therapeutic options are still needed for this patient population,” said Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. “We look forward to continued discussions with the FDA as we take the next steps in the regulatory process for axitinib.”
Axitinib is an oral therapy that was designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, receptors that can influence tumour growth, vascular angiogenesis and progression of cancer (the spread of tumours).
The ODAC panel members reviewed data on axitinib, including results from the phase III AXIS trial of patients whose disease had progressed following treatment with one systemic therapy.
Axitinib has been widely studied in a broad clinical development program, evaluating its efficacy and safety in more than 2,500 patients across several tumour types. Axitinib is also being investigated in a randomized phase III clinical trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized phase II clinical trial for the treatment of hepatocellular carcinoma.
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