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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Cell Therapeutics CTIC FDA Application Approval

August 24, 2009 - Shares of Cell Therapeutics, Inc. (CTIC) are set to open up premarket at $1.80 in about an hour as the FDA has approved the application for pixantrone for standard review. Fast Track status will be ruled on by 9/4/09. If CTIC can get fast track status, there will be an FDA approval ruling in late December. Check out my CTIC Technical Analysis

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Cell Therapeutics, Inc. (CTIC) FDA Application News

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.

About Pixantrone

Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although anthracyclines are sufficiently effective to be used as first-line (initial) treatment, anthracyclines cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if the patient's disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. The FDA is required to set an action date for review of an application 74 days after the initial submission of the NDA. CTI expects to receive the action date for this drug candidate from the FDA and a final decision on review status on September 4th, 2009. Full Article

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