Talon Marqibo’s Confirmatory Trial Plan May Need To Be Reworked
FDA advisory committee members express concern about the toxicity of Marqibo in the elderly patients expected to enroll in the Phase III confirmatory study for advanced acute lymphoblastic leukemia.
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Talon is preparing to launch the leukemia drug on its own in the first quarter of 2013 but remains in talks with potential strategic partners. The company agreed to monitor whether clinical practices experience safety or technical problems while following the 26-step process for preparing the drug for administration.
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.
A split Oncologic Drugs Advisory Committee vote moves Talon Therapeutics’ Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia one step closer to accelerated approval.