<em>Marqibo </em>Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial

Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial

10 Aug 2012

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...