Marqibo Advisory Committee Review Will Consider Benefit Of Partial Response
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Oncologic Drugs Advisory Committee will consider whether partial responses are likely to predict clinical benefit of Inex/Enzon's liposomal vincristine injection for non-Hodgkin's lymphoma at its Dec. 1 meeting. The committee will also consider Marqibo's benefit over existing therapies.
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Treatments described in literature constitute "available therapy" to treat relapsed, aggressive non-Hodgkin's lymphoma, cmte. says. Partial responses seen in the pivotal trial of the liposomal vincristine treatment are not reasonably likely to predict a clinical benefit, cmte. finds.
Inex/Enzon's Marqibo Not Eligible For Accelerated Approval, Committee Says
Treatments described in literature constitute "available therapy" to treat relapsed, aggressive non-Hodgkin's lymphoma, cmte. says. Partial responses seen in the pivotal trial of the liposomal vincristine treatment are not reasonably likely to predict a clinical benefit, cmte. finds.
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