The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted unanimously in support of GlaxoSmithKline’s (GSK) Votrient, an investigational medicine to treat kidney cancer.
The panel voted that the benefit-to-risk profile for Votrient (pazopanib) is acceptable for patients with advanced renal cell carcinoma.
Pazopanib is an investigational new medicine that may prevent the growth of new blood vessels to tumours, a process known as angiogenesis.
GSK Oncology R&D Unit vice-president Rafael Amado said that the company was looking forward towards the approval of pazopanib.
“The committee’s recommendation in support of pazopanib is an important step towards bringing a new oral treatment option to advanced renal cell cancer patients,” Amado said.
The committee’s decision was based on Phase III pivotal trial data presented at the American Society of Clinical Oncology 2009 annual meeting.