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Matrix IntraDose committee review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

At Sept. 10 meeting, the FDA Oncology Drugs Advisory Committee votes unanimously that Matrix's IntraDose (cisplatin/epinephrine) was not shown to be safe and effective in treatment of symptomatic recurrent head and neck squamous cell carcinoma in patients not considered curable with surgery or radiotherapy. Committee members expressed doubt about the clinical benefit of the agent and criticized the clinical benefit measurement tool used in IntraDose trials. The panel also voted against accelerated approval by a nine to three vote, with one abstention. The group encouraged Matrix to develop better designed trials with larger patient populations
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