Pfizer says FDA permits new data on Sutent label

This new indication is based on results of a large phase III trial which showed prolonged progression-free survival.

Sutent was originally approved in January 2006 for the treatment of advanced kidney cancer under the accelerated approval provision, based on partial response rates and duration of response. With the new labeling, the accelerated approval has been converted to regular approval.

In a phase III trial, patients with metastatic renal cell carcinoma (RCC) received either Sutent or the comparator interferon-alfa (IFN infinity), the current standard of care.

Patients taking Sutent achieved a median progression free survival of
11 months which was more than double the five-month median progression free survival observed with IFN infinity;

“For many years, the options available for people with metastatic kidney cancer have been very limited,” said Dr Robert Motzer, attending physician at Memorial Sloan-Kettering Cancer Center. “To have such a high percent of patients respond to this treatment is remarkable and a sign of the significant benefit Sutent may bring to patients fighting this deadly cancer.”

Sutent is also indicated for the treatment of gastrointestinal stromal tumors after disease progression on or intolerance to imatinib mesylate.