The FDA’s Oncologic Drugs Advisory Committee, in a unanimous vote, agreed that data for the investigational drug axitinib (Pfizer) support a favorable benefit/risk profile for treating patients with advanced renal cell carcinoma (RCC) following failure of first-line systemic therapy.
The FDA will consider the committee’s finding when making its decision whether to approve Pfizer’s New Drug Application for axitinib as a treatment for advanced RCC.
Axitinib is an oral therapy that selectively inhibits vascular endothelial growth factor receptors that influence tumor growth and progression. It has been tested in more than 2,500 patients across several tumor types for its efficacy and safety. The drug is also currently being investigated in a randomized phase 3 clinical trial in treatment-naïve patients as well as a randomized phase 2 trial for hepatocellular carcinoma treatment.