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FDA panel to review resubmitted NDA for pixantrone


SEATTLE — The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

"We are pleased the FDA Office of Oncology Drug Products chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs that we believe addresses the issues raised in the OODP complete response letter of April 2010," Cell Therapeutics CEO James Bianco said. "We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents."

Cell Therapeutics noted that while the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the agency itself.

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