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Melblez ODAC Review May Test The Outer Limits Of Toxicity

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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