FDA committee won't recommend approval for non-Hodgkin’s lymphoma treatment

GAITHERSBURG, Md. A Food and Drug Administration advisory committee declined to recommend approval for a cancer drug made by Cell Therapeutics, the company announced Monday.

Cell Therapeutics said the FDA’s Oncologic Drugs Advisory Committee voted unanimously that data from clinical trials of pixantrone, a treatment for non-Hodgkin’s lymphoma, did not support its approval. Pixantrone would have been the first drug to treat relapsed or refractory NHL in patients who had received two or more prior therapies.

The FDA is not bound by the recommendations of advisory committees, and the agency is expected to decide whether or not to approve pixantrone on April 23. It does, however, take the recommendations into account when deciding whether or not to approve a drug, and the committee’s vote will likely diminish pixantrone’s chances for winning approval.

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