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Cancer Clinical Benefit Tool Needed For Local Therapies -IntraDose Cmte

Executive Summary

An effective tool needs to be developed to assess the clinical benefit of local cancer therapies, FDA's Oncologic Drugs Advisory Committee concluded Sept. 10 in voting down Matrix' IntraDose.

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Matrix' IntraDose (cisplatin/epinephrine injectable gel) receives "not approvable" letter from FDA Nov. 2. The letter reiterates agency concerns raised at the Sept. 10 advisory committee meeting for the head and neck cancer agent, Matrix says (1"The Pink Sheet" Sept. 24, p. 30). The company is "continuing to explore with the FDA the next steps for IntraDose." Phase II trials for other cancer indications will not proceed to Phase III, Matrix says...

Matrix IntraDose “not approvable”

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