Leukemia

Hana Biosciences announces SPA filing for Marqibo in relapsed acute lymphoblastic leukemia

Published in Drug Law Weekly, January 16th, 2007

Hana Biosciences (HNAB), a biopharmaceutical company focused on advancing cancer care, announced the filing of a request for a special protocol assessment (SPA) with the U.S. Food & Drug Administration (FDA) for the design of a proposed registration trial for Marqibo (vincristine sulfate liposomes injection) in adults with acute lymphoblastic leukemia (ALL) in second relapse and beyond.

"We are pleased to have the opportunity to obtain feedback and guidance from the FDA on our pivotal trial," stated Mark Ahn, PhD, president and CEO. "We believe this regulatory mechanism provides an important step forward in our clinical development for Marqibo."

The...

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Source: Drug Law Weekly (2007-01-16)

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