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"This study adds to recently published First-line Indolent Trial (FIT)data indicating that the addition of Zevalin in patients who respond tofirst-line treatment of follicular non-Hodgkin's lymphoma patients may enhancethe depth of response, even in patients whose induction therapy includedrituximab-containing regimens," noted Jack Singer, M.D., Chief Medical Officerat Cell Therapeutics.
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This trial enrolled 60 patients of which 55 patients completed allprotocol therapy. Patients who had received no prior therapy withchemotherapy or monoclonal antibody received standard dose CHOP-R for 3 cyclesfollowed by Zevalin then were treated with rituximab weekly for 4 doses.CHOP-R related toxicities included grade 3 to 4 neutropenia occurred in 23(39%) patients and grade 3 to 4 thrombocytopenia occurred in 3 (5%) patients.The most frequent toxicity associated with Zevalin was myelosuppression.Grade 3 to 4 neutropenia occurred in 28 (51%) of patients with one incidenceof febrile neutropenia requiring hospitalization. Grade 3 to 4thrombocytopenia occurred in 44% of patients. However, all 55 patients whoreceived Zevalin had normal white blood counts and platelet counts by after 12weeks following administration.
Zevalin is currently approved in the United States for the treatment ofpatients with relapsed or refractory, low-grade or follicular B-cellnon-Hodgkin's lymphoma (NHL), including patients with rituximab refractoryfollicular NHL. The Zevalin therapeutic regimen has been given acceleratedapproval for the treatment of relapsed or refractory, rituximab-naive,low-grade and follicular NHL based on studies using an endpoint of overallresponse rate, which is a surrogate for progression free survival.
About Zevalin(R)
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy calledradioimmunotherapy and is indicated as part of the Zevalin therapeutic regimenfor treatment of relapsed or refractory, low-grade or follicular B-cellnon-Hodgkin's lymphoma, including patients with rituximab refractoryfollicular NHL. Zevalin is indicated, under accelerated approval, for thetreatment of relapsed or refractory, rituximab-naïve, low-grade and follicularNHL based on studies using a surrogate endpoint of overall response rate. Itwas approved by the FDA in February of 2002 as the firstradioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex haveoccurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90Zevalin administration results in severe and prolonged cytopenias in mostpatients. Severe cutaneous and mucocutaneous reactions have been reported. Themost serious adverse reactions of the Zevalin therapeutic regimen wereprimarily hematologic, including neutropenia, thrombocytopenia and anemia.Infusion-related toxicities were associated with pre-administration ofrituximab. The risk of hematologic toxicity correlated with the degree of bonemarrow involvement prior to Zevalin therapy. Myelodysplasia or acutemyelogenous leukemia was observed in 2 percent of patients (8 to 34 monthsafter treatment). Zevalin should only be used by health care professionalsqualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit www.zevalin.com for moreinformation.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation ofwhite blood cells and normally spreads through the lymphatic system, a systemof vessels that drains fluid from the body. NHL can be broadly classified intotwo main forms -- aggressive NHL, a rapidly spreading acute form of thedisease, and indolent NHL, which progresses more slowly. According to theNational Cancer Institute's SEER database there were nearly 400,000 people inthe U.S. with NHL in 2004. The American Cancer Society estimates that in theUnited States 66,120 people are expected to be diagnosed with NHL in 2008.Additionally, approximately 19,160 are expected to die from this disease in2008.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products aimed at making cancermore treatable. For additional information, please visitwww.celltherapeutics.com.
This press release includes forward-looking statements that involve anumber of risks and uncertainties, the outcome of which could materiallyand/or adversely affect actual future results. Specifically, the risks anduncertainties that could affect the development of Zevalin include risksassociated with preclinical and clinical developments in the biopharmaceuticalindustry in general and with Zevalin in particular including, withoutlimitation, the potential for Zevalin to be proved safe and effective for thetreatment of additional indications as noted in this publication or any otherindication, determinations by regulatory, patent and administrativegovernmental authorities, competitive factors, technological developments, andcosts of developing, producing and selling Zevalin. You should also review therisk factors listed or described from time to time in the Company's filingswith the Securities and Exchange Commission including, without limitation, theCompany's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may berequired by law, CTI does not intend to update or alter its forward-lookingstatements whether as a result of new information, future events, orotherwise.Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: [email protected] www.CellTherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: [email protected] www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
