Liver damage caused by GlaxoSmithKline’s experimental kidney-cancer drug pazopanib is outweighed by the benefits, according to the US Food and Drug Administration (FDA) cancer-drug panel.
Voting unanimously in favour of the drug, panellists said that the side effects are not significantly worse than similar cancer drugs, and therefore acceptable.
Says chairman Dr Gary Lyman, of Duke University Medical Center: “I think it’s an efficacious drug with significant toxicity, but I think the benefit-to-risk ratio is favourable considering all the data presented here.”
However, to ensure that the drug’s liver toxicity does not increase over time, the panel said Glaxo must submit data from ongoing studies.
Dr Leonard Seeff, of the National Institutes of Health, said: “I think we need more information on this issue, and that can be accomplished by monitoring it.”
Glaxo vice president Rafael Amado said the endorsement is “an important step” toward bringing the drug to market. While the FDA often follows the advice of its panels, it is not obliged to do so.
Copyright Press Association 2009