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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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