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FDA Cleared Ixempra Despite Doubts Over Chance Of Showing Survival Benefit

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Doubts about the likelihood that the improvement in progression-free survival seen in a pivotal trial of Bristol-Myers Squibb's Ixempra (ixabepilone) will translate to an overall survival advantage could add to the controversy over the appropriateness of PFS as a surrogate for survival in metastatic breast cancer.

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