FDA clears RCC label change for Sutent

US drug giant Pfizer says that the Food and Drug Administration has approved new labeling for its oncology agent Sutent (sunitinib malate). The revised indication now covers the product's use as a first-line treatment for renal cell carcinoma, based on the results of a Phase III trial which showed that it prolonged progression-free survival.

The drug was originally approved as a therapy for kidney cancer early last year (Marketletter February 6, 2006) under the FDA's accelerated approval program, based on its performance in trials. Subsequent assessment of the agent demonstrated that patients treated with the compound achieved an average 11 months of progression-free survival, nearly double the five month average in patients receiving interferon alfa-based therapy.

In addition, the product brought about nearly five times the rate of objective response than IFN alpha (27.5% versus 5.3%), and was associated with fewer adverse-events that lead to treatment discontinuation.