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Cell Therapeutics - Facing The Big Test

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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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