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FDA reviews Matrix NDA

September 7, 2001 7:00 AM UTC

The FDA on Friday released its medical review of an NDA filed by MATX for IntraDose cisplatin/epinephrine injectable gel to treat head and neck cancer, recommending against approval of the product. On Monday, the FDA's Oncologic Drugs Advisory Committee will discuss the NDA.

The medical review stated the recommendation "is based on the finding of extremely limited efficacy and moderate to severe toxicity reproducibly demonstrated in two clinical trials." The document also noted that data from two pivotal IntraDose trials, Study 414 and Study 514, "strongly suggest that the risk (which is generally moderate but occasionally severe) of administering IntraDose outweighs the small clinical benefit conferred on the studied population." ...