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FDA Grants Accelerated Approval for Talon's Marqibo

By Peter Winter
BioWorld Insight Editor

Friday, August 10, 2012
It has been a long and turbulent road for Marqibo (vincristine sulfate liposome injection), but South San Francisco-based Talon Therapeutics Inc. finally brought it over the goal line. The product received FDA accelerated approval Thursday based on a single-arm study for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.

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