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Delcath’s Melblez Chemosaturation System To Face ODAC Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Oncologic Drugs Advisory Committee will review the drug/device combination for treatment of patients with unresectable ocular melanoma that is metastatic to the liver. The system, which uses the chemotherapy drug melphalan, has shown significant improvement in hepatic progression-free survival.

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Delcath Sticks With Melblez Chemosaturation But Dumps CEO On FDA Rebuff

FDA’s “complete response” letter requesting further studies is no surprise after a scathing ODAC assessment in May, but with an interim CEO team in place, the company says it’s ready to work things out with regulators.

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.

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.

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