The panel of outside cancer experts is being asked to review the risks and benefits of Marqibo as a treatment for patients with acute lymphoblastic leukemia (ALL) who have run out of other treatment options.
Marqibo's benefit is in dispute. According to Talon's analysis of the pivotal trial, 20% of ALL patients achieved a complete or near-complete tumor response -- the primary endpoint of the study. The median duration of response for those patients with a CR/CRi was 5.4 months with a median overall survival of 7.4 months.FDA, however, conducted its own analysis of the same trial and found that 15% of ALL patients achieved a complete or near-complete response. FDA also determined that a complete response in patients lasted less than one month. FDA's reviewers questioned Marqibo's safety, particularly high rates of nerve pain. Talon is expected to argue for Marqibo's approval based on the fact that patients entering the study with advanced ALL that was no longer responding to currently approved therapies. Wednesday's panel will vote on whether or not to recommend Marqibo's approval. The final decision is left to FDA, which is expected to decide by on or before May 13. --Written by Adam Feuerstein in Boston.
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