Inex/Enzon's Marqibo Not Eligible For Accelerated Approval, Committee Says
This article was originally published in The Pink Sheet Daily
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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With Talon offering a single Phase II trial to support its NDA for Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia, everything may hinge on the disagreement between the sponsor and FDA over whether eight patients or 13 out of 65 experienced some type of complete response.
Biotech formerly known as Hana Biosciences submits NDA for the nano-encapsulated vincristine for use as salvage in adults with Ph- ALL.