Coming out of its advisory committee review, Delcath Systems Inc.’s chemosaturation system Melblez Kit could be viewed as an example of a therapy with a clearly failed risk/benefit profile where the toxicity negates any demonstrated treatment advantage of the product.
On May 2, FDA’s Oncologic Drugs Advisory Committee voted 16-0 against approval of the drug/device combination to treat resectable ocular melanoma that is metastatic to the liver
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