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news.Pfizer Japan has received manufacturing and marketing authorization approval for Sutent capsule 12.5mg for gastrointestinal stromal tumor after failure of imatinib treatment due to resistance and for renal cell carcinoma not indicated for curative resection and metastatic renal cell carcinoma.
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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.