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Amgen's T-Vec Receives Poor FDA Staff Review
The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.
FDA staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study.
The reviewers said in documents made public on Monday that it was unclear whether the treatment, a cancer-killing virus called talimogene laherparepvec or "T-Vec", improved overall survival, raising questions over its effectiveness. The review comes two days before a panel of FDA advisers votes on whether T-Vec should be approved to treat melanoma.
The FDA typically accepts the panel's recommendations.
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