The European Commission’s conditional authorization of Sutent (sunitinib malate) to treat advanced and/or metastatic renal cell carcinoma (mRCC) after failure of interferon alfa and interleukin-2 therapies is based on data from two phase II open-label studies. In these trials, Sutent-treated patients experienced an objective response rate of 38% in the confirmatory study and 36.5% in the supportive study.
The mRCC approval is conditional until the Committee for Human Medical Products (CHMP) reviews Sutent phase III study data. Pfizer plans to submit this data in August.
The gastrointestinal stromal tumor (GIST) approval is based on data from a phase III study involving 312 patients with imatinib-resistant or intolerant metastatic GIST. The median time to tumor progression was significantly prolonged to 28.9 weeks for Sutent-treated patients versus 5.1 weeks for patients who received placebo.
“For many years, the options available for people with metastatic kidney cancer have been very limited,” said Dr Sylvie Negrier, professor of medical oncology at Centre Leon Berard in Lyon, France. “To have approximately 35% of patients in the pivotal study respond to this treatment is truly remarkable. Also, a large majority of patients were able to control their disease over time.”