Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial
This article was originally published in The Pink Sheet Daily
Executive Summary
Talon’s liposomal vincristine receives accelerated approval for refractory Ph- acute lymphoblastic leukemia, with a requirement for a confirmatory trial. The firm has a first-line trial under way for that purpose, but it wasn’t well received by the Oncologic Drugs Advisory Committee.