will be bringing its lymphoma drug pixantrone in front of a Food and Drug Administration advisory committee meeting in February, according to a
in the Federal Register.
The FDA's Oncologic Drug Advisory Committee will convene Feb. 10 to review Cell Therapeutics' pixantrone for the treatment of aggressive non-Hodgkin's lymphoma.
The advisory panel meeting set for February means pixantrone will not be approved this month, as Cell Therapeutics' CEO Jim Bianco had
in recent meetings.
FDA advisory committees generally review an experimental drug's efficacy and safety data and then make a recommendation to the FDA about whether or not the drug should be approved. The final approval decision rests with FDA. In this case, the agency's approval decision deadline for pixantrone is April 23, 2010.
Also being reviewed at the February advisory panel meeting is
omacetaxine for the treatment of adults with chronic myeloid leukemia.
-- Reported by Adam Feuerstein in Boston
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