Sunitinib Approved in Japan for GIST and Renal Cell Carcinoma

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Title: Sunitinib Approved in Japan for GIST and Renal Cell Carcinoma
URL: http://www.pslgroup.com/dg/21FF0E.htm
Doctor's Guide
April 22, 2008

NEW YORK -- April 22, 2008 -- The kinase inhibitor sunitinib malate (Sutent) has been approved in Japan for multiple indications: gastrointestinal stromal tumour (GIST) after failure of imatinib treatment due to resistance, renal cell carcinoma (RCC) not indicated for curative resection, and metastatic renal cell carcinoma.

Sunitinib, an oral kinase inhibitor, is a low-molecular-weight compound capable of selectively inhibiting the tyrosine kinase receptor involved in tumour growth and vascularisation. In the treatment of RCC, sunitinib 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-alfa and KIT (CD117).

In a phase 3 clinical study involving patients with GIST resistant to imatinib and patients with metastatic GIST who could not tolerate imatinib, the median time to tumour progression was significantly longer in the sunitinib-treated group (27.3 weeks) compared with the placebo group (6.4 weeks).

In another phase 3 clinical study designed to determine a drug of first choice for the treatment of advanced RCC, patients with RCC who had received no prior drug therapy were treated with either interferon (IFN)-alfa or sunitinib. The median progression-free survival period in the sunitinib-treated group was 47.3 versus 22.0 weeks in the IFN-alfa-treated group. Furthermore, the response rate to sunitinib therapy was 5 times higher than that in the IFN-alfa group (27.5% vs 5.3%). The efficacy and tolerability of this drug in Japanese patients have been demonstrated in domestic phase 1 and 2 clinical studies.

As part of the approval for the manufacturing and marketing authorisation of this drug, the Japanese regulatory authority made it obligatory for Pfizer Japan Inc to conduct a postmarketing survey of all patients treated with the drug until data from a certain number of cases are collected so that necessary measures can be taken as soon as possible to ensure appropriate use of the drug.

To assure safety of patients receiving treatment with sunitinib and to facilitate its proper use, Pfizer Japan will distribute this drug only to facilities and physicians satisfying certain requirements that will be established. The manufacturer will conduct a special survey in which all patients treated with sunitinib will be enrolled. Furthermore, Pfizer Japan will undertake campaigns addressed to physicians who prescribe sunitinib so that each patient and his/her family members are well informed of its efficacy and safety, and so that physicians begin treatment only after informed consent has been obtained from each patient.

Sunitinib was approved in the United States in January 2006. To date, it has been approved in more than 75 countries worldwide, including several countries in Europe. The use of sunitinib is recommended by the "Guidelines on Treatment of GIST and RCC" prepared by the US National Comprehensive Cancer Network. Japan applied for approval of sunitinib in December 2006.

SOURCE: Pfizer Inc

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