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Eisai Makes Oncology Debut With Halaven, But Development Question Marks Remain

This article was originally published in The Pink Sheet Daily

Executive Summary

Already in the small minority of drugs to gain approval via overall survival, Eisai's ability to gain additional indications for Halaven may hinge on improving the drug's progression-free survival data.

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Even though Eisai’s Halaven showed an unprecedented overall survival effect in a very tough-to-treat breast cancer population, the drug appears to have flopped in a head-to-head study against Xeloda in an earlier line of therapy. Nevertheless, Eisai vows to pursue a regulatory filing that would expand the drug’s label, as planned.

Eisai Will Try For Halaven Label Expansion, Despite Phase III Failure

Even though Eisai’s Halaven showed an unprecedented overall survival effect in a very tough-to-treat breast cancer population, the drug appears to have flopped in a head-to-head study against Xeloda in an earlier line of therapy. Nevertheless, Eisai vows to pursue a regulatory filing that would expand the drug’s label, as planned.

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