EC gives conditional approval of Pfizer's Sutent in RCC

US drug behemoth Pfizer says that it has received conditional marketing approval from the European Commission for Sutent (sunitinib malate), as a treatment for advanced or metastatic renal cell carcinoma that has not responded to interferon alfa and interleukin-2 therapies. The Commission's decision, which will remain conditional until it has reviewed data from a Phase III trial, is based on data from two open-label studies that demonstrated an objective response rate of 38% (and 36.5% in a confirmatory trial) in patients treated with the drug. The company added that the median response duration has not yet been reached in ongoing trials.

Stutent received US Food and Drug Administration approval for use in gastrointestinal stromal tumors (GIST) earlier this year (Marketletter February 6), and has been granted Orphan Drug status by the European Medicines Agency (EMEA), for both the GIST and RCC indications.