Monday, April 21, 2008

Pfizer Japan Receives Manufacturing and Marketing Authorization for Sutent

Apr 21, 2008 - Pfizer Japan Inc announced that on April 16, the company received an approval for the manufacturing and marketing authorization of the anti-tumor drug/kinase inhibitor "SUTENT(R) 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-(alpha) and KIT (CD117).

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