The Food and Drug Administration's Oncologic Drugs Advisory Committee is scheduled to review Cell Therapeutics Inc.'s (CTIC) New Drug Application for Pixantrone for the treatment of relapsed and refractory non-Hodgkin's lymphoma on February 10.
The company began a rolling New Drug Application submission for Pixantrone to the FDA in April 2009 and completed the submission in June 2009. The NDA submission was based on a phase III single-agent Pixantrone trial dubbed EXTEND, or PIX 301 in patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines.
The FDA is expected to make a final decision on Pixantrone on April 23.
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