Melblez ODAC Review May Test The Outer Limits Of Toxicity

Significant improvement in hepatic progression-free survival was inadequate to outweigh significant toxicities and a negative overall survival trend as the panel unanimously opposed approval of Delcath’s Melblez Kit May 2. But the review gave FDA a platform to discuss the tradeoffs involved in oncology drug reviews and the balance between risks and benefits.

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...

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