Healthcare Industry News: ibritumomab tiuxetan
News Release - October 20, 2008
High-Dose Zevalin(R) With Tandem Stem Cell Infusion Produces 87 Percent Overall Survival in Relapsed/Refractory or High Risk Non-Hodgkin's LymphomaNovel Outpatient Regimen Pioneered by Investigators from Tumor Institute in Milan
SEATTLE, Oct. 20 (Healthcare Sales & Marketing Network) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Journal of Clinical Oncology has published the results of an innovative study that investigated high (bone marrow ablative) dose Zevalin« ([90Y]-ibritumomab tiuxetan) followed by autologous stem cell infusions among 30 patients (median age 62 years) with relapsed/refractory or high risk aggressive non-Hodgkin's lymphoma (NHL) not eligible for a chemotherapy-based transplant. High-dose myeloablative chemotherapy is an effective therapy for NHL but because it is associated with significant toxicities it is usually reserved for clinically fit and younger patients and therefore is not an option for many due to the average age of NHL patients being approximately 60 years old. In this study, three cycles of conventional chemotherapy were given followed by high dose chemotherapy with a stem cell rescue and then followed by up to three times the standard dose of Zevalin with an additional stem cell rescue. This treatment regimen resulted in 83 percent of patients achieving a disease free state with a projected overall survival of 87 percent after a median follow up of 30 months.
"Our results suggest that the use of high-dose Zevalin for these patients provides a significant clinical benefit and is very well tolerated," said Alessandro M. Gianni, M.D., Full Professor of Medical Oncology and Director of the School of Specialization in Medical Oncology at the University of Milan. "We are encouraged by the outcome of the study as this regimen could be applicable to the vast majority of high risk or relapsed non-Hodgkin's lymphoma patients."
High-dose Zevalin was well tolerated and no deaths were noted with this regimen. The expected severe marrow suppression associated with myeloablative treatment was seen but patients began to recover neutrophil and platelet counts within 3 weeks. Only minor non-hematologic toxicities were observed. Infections, none greater than grade 3, were noted in 8 patients (27 %) but hospitalization for grade 3 febrile neutropenia was required in only 3 patients. The authors concluded "the mild hematologic toxicity was unprecedented for a myeloablative regimen." The authors go on to state that "A notable and distinct difference in our study from virtually all other regimens of myeloablative polychemotherapy is the nearly complete absence of non- hematologic toxicity. Despite advanced age and presence of co-morbidities in many patients, none experienced vital organ toxicities of any grade. Mucositis, a major cause of toxicity and even infectious mortality after myeloablative treatments, was absent, and all patients were able to maintain normal oral intake of food and water. The excellent tolerability of myeloablative radioimmunotherapy was noteworthy in that 19 patients (63 percent) had previously not met the eligibility criteria for chemotherapy- based autotransplantation regimens as a result of elderly age and/or comorbidities."
"We continue to be impressed with the potential for radioimmunotherapy as an adjunct to, or as in this study, a partial replacement for high-dose chemotherapy in autotransplantation for relapsed-refractory or high risk CD-20 positive B-cell non-Hodgkin's lymphomas," noted Jack Singer, M.D., Chief Medical Officer at Cell Therapeutics. "This investigational regimen adds to the growing body of clinical trial data indicating that Zevalin at higher than FDA approved doses with a stem cell rescue, may provide an added clinical benefit when added to either traditional myeloablative doses of chemotherapy, or as in the present study, added to high-doses of standard chemotherapy."
Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. The Zevalin therapeutic regimen has been given accelerated approval for the treatment of relapsed or refractory, rituximab-naive, low- grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.
Zevalin« (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-na´ve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan«) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that 66,120 people will be diagnosed with NHL in 2008 and more than 19,000 are expected to die.
About Cell Therapeutics, Inc.
Headquartered in Seattle, 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 http://www.celltherapeutics.com.
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. Specifically, the risks and uncertainties that could affect the development of Zevalin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential for Zevalin to be proved safe and effective for the treatment of additional indications as noted in this publication or any other indication, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin. You should also review the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company'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.
Source: Cell Therapeutics
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