Singapore, April 23, 2008: Pfizer Japan announced that it received an approval for the manufacturing and marketing authorization of the anti-tumor drug/kinase inhibitor “Sutent Capsule 12.5 mg” (sunitinib malate) indicated for Gastrointestinal Stromal Tumor (GIST) after failure of imatinib treatment due to resistance and for Renal Cell Carcinoma (RCC) not indicated for curative resection and Metastatic Renal Cell Carcinoma.

 

Sutent is a new oral-dose anti-tumor drug referred to as a kinase inhibitor, and a low-molecular-weight compound capable of selectively inhibiting the tyrosine kinase receptor involved in tumor growth and vascularization. In the treatment of renal cell carcinoma, Sutent suppresses the growth primarily by inhibiting the intracellular signal transduction related to the vascular endothelial growth factor receptor (VEGFR) and the platelet derived growth factor receptor (PDGFR). It also suppresses the growth of GIST primarily by inhibiting the intracellular signal transduction related to PDGFR-α and KIT (CD117).

 

As part of the approval for the manufacturing and marketing authorization of this drug, the Japanese regulatory authority made it obligatory for Pfizer Japan to conduct a post-marketing survey, covering all patients treated with the drug, until data from a certain number of cases will be collected, in order to collect data on the safety and efficacy of the drug as soon as possible and to take necessary measures to ensure appropriate use of the drug.

 

To assure safety of patients receiving treatment with Sutent and to facilitate its proper use, Pfizer Japan will distribute this drug only to facilities and physicians satisfying the requirements planned to be prepared and will conduct a special survey in which all patients treated with this drug will be enrolled.

 

Sutent was approved in January 2006 in the USA. To date, it has been approved in more than 75 countries worldwide, including several countries in Europe. The use of Sutent is recommended by the “Guidelines on Treatment of GIST and RCC” prepared by the National Comprehensive Cancer Network (NCCN), USA. In Japan, an application for approval of Sutent was filed in December 2006 with the Ministry of Health, Labour and Welfare, and it has just been approved.