Inex/Enzon Non-Hodgkin’s Lymphoma Product
This article was originally published in The Pink Sheet Daily
Executive Summary
Inex and Enzon's liposomal vincristine injection will have the brand name Marqibo
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Marqibo Advisory Committee Review Will Consider Benefit Of Partial Response
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.
Marqibo Advisory Committee Review Will Consider Benefit Of Partial Response
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.
Inex/Enzon’s Marqibo Will Get Oncologic Advisory Cmte. Review Dec. 1, Firms Say
The sponsors are seeking a monotherapy indication for treatment of relapsed aggressive non-Hodgkin’s lymphoma in patients previously treated with at least two combination chemotherapy regimens. The NDA's user fee date is Jan. 15.