Talon Marqibo’s Fate May Hang On Adjudication Of Trial Subjects

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.