Talon May Soon Have First Marqibo Approval In Its Grasp
This article was originally published in The Pink Sheet Daily
Biotech formerly known as Hana Biosciences submits NDA for the nano-encapsulated vincristine for use as salvage in adults with Ph- ALL.
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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.
Deal valued at up to $50 million will allow Hana to proceed with development of oncology candidates, Hana said.
Hana also drops its SPA request for Marqibo, citing a change in FDA policy on open-label oncology trials.