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Uphill battle for Amgen's T-Vec? FDA expresses 'uncertainty'

This article was originally published in Scrip

Executive Summary

FDA drug reviewers on 27 April questioned the study design and results of Amgen's oncolytic immunotherapy T-Vec (talimogene laherparepvec) – declaring there is "uncertainty" about the meaningfulness of the observed responses in the firm's single Phase III study of the product in treating injectable regionally or distantly metastatic melanoma.


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