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Phase II ALL a go for Hana Marqibo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Hana Biosciences has initiated a Phase II Marqibo (vincristine liposomal injection) trial for use in acute lymphoblastic leukemia after acquiring the formulation from Inex (1Pharmaceutical Approvals Monthly April 2006, p. 7). FDA issued a "not approvable" letter to Inex for Marqibo for treatment of relapsed aggressive non-Hodgkin's lymphoma in 2005. The company hopes to initiate a Phase III ALL trial by the end of 2006...

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