Pixuvri is available in the E.U. through Named Patient Programs in those countries where it is not available commercially.
Pixuvri does not have marketing approval in
the United States
About Conditional Marketing Authorization
Similar to accelerated approval regulations in
the United States
, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit as determined by the assessment conducted by the European Medicines Agency. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorisation for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled phase III clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by
About Non-Hodgkin's Lymphoma
NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.
There are many subtypes of NHL, but aggressive B cell NHL is the most common and accounts for about 50% of NHL cases.
After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease.
Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50% are expected not to respond.
For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only.
Pixuvri is the first treatment to receive E.U. regulatory approval for treatment of patients with multiply relapsed or refractory aggressive B-cell NHL.
1. European Cancer Observatory, Cancer Fact Sheets, 20082. Harris NL, et al. Ann Oncol. 1999;10(12):1419-323. Pettengell R, Coiffier B, Narayanan G et al.
2012. Published online
2012. DOI:10:1-16/S1470-2045(12)70212-74. Cavalletti E, Crippa L, Mainardi P et al.
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2007;25:187-955. Hagemeister FB. Cancer Chemother Pharmacol 2002;49(suppl 1):S13-206. Cavalletti E, Crippa L, Mainardi P et al.
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About Cell Therapeutics, Inc.
, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit
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This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Pixuvri in particular including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the U.S. Food and Drug Administration, that CTI may not market and commercialize Pixuvri in the E.U. as planned, that CTI may not launch Pixuvri in the E.U. this year as planned, that CTI may not be able to complete the PIX306 clinical trial of Pixuvri-rituximab compared to gemcitabine-rituximab in patients who have relapsed after 1 to 3 prior regimens for aggressive B cell NHL and who are not eligible for autologous stem cell transplant by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all, that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX301 trial, that the conditional marketing authorization for Pixuvri may not be renewed, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that CTI's average net operating burn rate may increase and CTI's ability to continue to raise capital as needed to fund its operations in general, and, including, without limitation, competitive factors, technological developments, costs of developing, producing, and selling Pixuvri, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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