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Wyeth’s Torisel clears FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth will launch its advanced kidney cancer treatment Torisel (temsirolimus) in July. FDA approved the novel mTOR inhibitor May 30 for the treatment of renal cell carcinoma. Torisel's main competition is Bayer/Onyx's Nexavar (sorafenib) and Pfizer's Sutent (sunitinib). The Torisel NDA was submitted Oct. 5, 2006, and received a priority review, but the review action date was extended to July 5 after FDA requested additional information. Wyeth has also initiated a trial of temsirolimus in mantle cell lymphoma and is looking at the drug in combination with Nexavar and Sutent...

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