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Erivedge Development Timeline

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A timeline chronicling the development history of Genentech’s vismodegib.

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Erivedge Reviewers

FDA staff that participated in the review of Genentech’s basal cell carcinoma treatment vismodegib.

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Response rates of 30%-43% and a 7.6-month median duration of response were sufficiently clinically meaningful to allow FDA approval of Genentech’s basal cell carcinoma treatment on the basis of a non-randomized study.

Will The New Math Of Oncology Drug Review Times Carry Over Into PDUFA V?

The Office of Hematology and Oncology Products originally targeted a four-month review goal for vismodegib, but review staff deemed such a compressed timeline not feasible.

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