Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Apr 28 2010

Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. 

Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.