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Halaven Survival Data Was Gold-Standard Lining In Forced Shift From Accelerated To Full Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Eisai’s development plan for Halaven was derailed by FDA’s approval of Ixempra in the same metastatic breast cancer indication, precluding the planned accelerated approval filing and redirecting the sponsor to a full approval track, but it also meant eribulin received the first approval in its highly refractory patient population ever to be based on overall 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.

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