Talon’s Marqibo Gets Lukewarm Endorsement From ODAC
This article was originally published in The Pink Sheet Daily
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.
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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.
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.
With Talon offering a single Phase II trial to support its NDA for Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia, everything may hinge on the disagreement between the sponsor and FDA over whether eight patients or 13 out of 65 experienced some type of complete response.