BMS withdraws Ixempra in Europe
Bristol-Myers Squibb has withdrawn its application to market Ixempra (ixabepilone) in Europe, the European Medicines Agency announced March 19. The metastatic breast cancer drug gained U.S. approval for a fourth-line indication as monotherapy in a salvage setting, and as third-line combination therapy based on progression-free survival - an endpoint that FDA was concerned would not translate to overall survival benefit, according to agency review documents (1Pharmaceutical Approvals Monthly, June 1, 2008, p. 36). In Europe, Ixempra was proposed for in combination with capecitabine to treat locally advanced or metastatic breast cancer after failure of previous cytotoxic chemotherapy treatments. It had received a negative opinion from CHMP
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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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