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Wyeth stops temsirolimus breast cancer program

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth is terminating a Phase III trial of oral temsirolimus in breast cancer based on an independent data monitoring committee's (IDMC) recommendation, the firm says March 16. However, the firm will continue development of the oncologic in renal cell carcinoma and mantle cell lymphoma. The discontinued first-line HORIZON trial was looking at temsirolimus oral tablets in combination with Novartis' Femara (letrozole) versus Femara alone. "The IDMC advised that continuation of the trial was unlikely to achieve the targeted level of efficacy for the combination therapy compared to letrozole alone," Wyeth says. The firm intends to file an NDA for RCC in the fourth quarter; the mantle cell lymphoma NDA is slated for the end of 2007...

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