An independent Food and Drug Administration (FDA) advisory panel, despite having no power to approve or deny drugs, has voted against AVEO and Astellas' new kidney cancer drug, tivozanib.
The panel cited evidence that the data from clinical trials was inconsistent and voted against a recommendation by 13-1. The group said that the drug does not demonstrate benefits that outweigh the risks and suggested another trial would be needed before the approval of tivozanib.
The recent clinical trial showed that tivozanib did delay disease progression in patients suffering from kidney cancer, but did not extend survival in a 517-patient cohort. The drug was compared to a competitor, nexavar, known generically as sorafenib, made by Beyer and Onyx Pharma.
The panel made it clear that in a cost-benefit analysis the drug was not beneficial in the long run. While the drug delayed the progression of disease by 20 percent, it increased the risk of death by 25 percent. Tivozanib had a patient survival of 28.8 months, while the competitor that is currently on the market allowed patients to live for 29.3 months on average.
"If we approve this drug based on this study how would we communicate to patients the potential 25 percent increase in the risk of death?" Jonathan Jarow, Medical Officer at the FDA, asked the panel.
Reuter reports that one of the panel members Lori Dodd, a mathematical statistician at the National Institutes of Health (NIH), said she was "angry" with what she perceived to be a poorly designed clinical trial program that potentially denied kidney cancer patients access to a new drug.
"I think if the trial had been conducted in a better way we would not be here," she said.
"While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients. We are committed to the RCC patient community and will work closely with the FDA to address the issues discussed by the panel today as the Agency continues its ongoing review of the New Drug Application for tivozanib." said Tuan Ha-Ngoc, president and chief executive officer of AVEO.
Tivozanib is meant to treat renal cell carcinoma (RCC), a cancer of the kidneys that is difficult to catch in early stages, by inhibiting the growth of new blood vessels, which tumors would otherwise promote the growth of due to an extreme hunger for nutrition and oxygen. The drug's target is all vascular endothelial growth factor (VEGF) receptors.
Globally, it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from renal cell carcinoma each year. RCC accounts for more than 90 percent of all kidney cancers.