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Talon Therapeutics, Inc. Message Board

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  • dinepat203 dinepat203 Mar 21, 2012 1:25 PM Flag


    SAN MATEO, Calif., March 21, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc., (OTCBB:TLON), announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo® (vincristine sulfate liposomes injection) seeking the indication for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA decision (PDUFA) date for Marqibo is May 13, 2012.
    "We are very pleased the majority of the ODAC members agree that Marqibo offers a meaningful benefit/risk ratio for a very rare patient population that has a grave prognosis and no current standard of treatment," stated Steven R. Deitcher, M.D., President, Chief Executive Officer and Board Member of Talon Therapeutics. "Based on prior FDA discussions, we have received Special Protocol Assessment (SPA) agreement for a large, randomized Phase 3 trial in front-line adult elderly ALL with sites currently open for enrollment. We look forward to working closely with the FDA in the coming weeks to address any remaining questions they may have."


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