Cell Therapeutics CTIC FDA Approval Decision Appealed

September 14, 2010 - The CTIC saga continues! Cell Therapeutics Inc. (CTIC) plans to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma.

Pixantrone NDA transferred to newly created Division of Hematologic Products

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its NDA for this patient group for which there are no currently approved drugs. The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process. CTI reached this decision by taking into account that CTI believes there are no approved or effective therapies for patients with relapsed or refractory aggressive NHL beyond second relapse, and that PIX 301 was the first and only randomized trial in this patient group to demonstrate significant improvement in clinically relevant endpoints including complete response rate, overall response rate, and progression free survival while being safe and effective in this indication. Full Press Release

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