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...