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Talon Marqibo’s Confirmatory Trial Plan May Need To Be Reworked

 
• By Martin Berman-Gorvine

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.

The Oncologic Drugs Advisory Committee may have voted narrowly for accelerated approval of Talon Therapeutics Inc. ’s Marqibo (vincristine sulfate liposomes injection), but even the yeas expressed nervousness about the design and even the feasibility of the confirmatory Phase III trial of the drug for advanced acute lymphoblastic leukemia, which is already under way.

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