The Oncology Drugs Advisory Committee (ODAC) unanimously voted to recommend the approval of axitinib (Inlyta), a tyrosine kinase inhibitor, for the second-line treatment of patients with advanced renal cell carcinoma (RCC).
The recommendation was based on the AXIS 1032 trial, a randomized, open-label, controlled, phase III multicenter study of 723 patients with advanced RCC. Patients were randomized to receive axitinib or sorafenib, both vascular endothelial growth factor (VEGF) inhibitors, with a primary endpoint of progression-free survival (PFS).
The median PFS for the axitinib arm of the trial was 6.7 months compared to 4.7 months in the sorafenib arm. (HR=0.67; 95% CI, 0.55-0.81). Adverse events were not out of the ordinary compared to other VEGF inhibitors. The most common adverse events included diarrhea, nausea, fatigue, asthenia, hypertension, and dermatologic events.
"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."
The FDA sought advice from the panel because of concerns regarding the origin of the PFS benefit demonstrated in the AXIS trial and to decide if the benefits of the drug outweighed the risks. The unanimous vote from the ODAC committee clears axitinib of these concerns.
There are currently 4 other VEGF inhibitors available for RCC, along with 2 drugs that inhibit mammalian target of rapamycin (mTOR).
Kidney cancer is the seventh most common form of cancer among men and the ninth among women in the United States. RCC is responsible for 85% of all cases of kidney cancer.