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Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial

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.

FDA has granted accelerated approval for Talon Therapeutics Inc. ’s Marqibo for a rare form of leukemia despite concerns raised by members of the Oncologic Drugs Advisory Committee that the confirmatory trial can be completed.

Marqibo, a liposomal form of vincristine, was approved Aug. 9 for treatment of patients with Philadelphia chromosome-negative acute lymphoblastic leukemia...

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