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.
You may also be interested in...
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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.