Rituximab maintenance therapy dramatically improves survival in lymphoma
Dec 13, 2005 - 3:36:00 PM, Reviewed by: Dr. Priya Saxena
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Based on this data, Roche will file today with the European authorities for a label extension for MabThera maintenance therapy for patients suffering from indolent lymphoma. In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, and around 40,000 are being treated for this disease.
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By Roche,
Two years of maintenance therapy with MabThera (rituximab) dramatically improves the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin�s Lymphoma (NHL). The trial showed that the risk of death is halved for patients who receive MabThera maintenance therapy, compared to those who receive no maintenance treatment, irrespective of their initial therapy. �We are conscious that these results open a new era in the management of indolent NHL�, said William M. Burns, CEO of the Pharmaceuticals Division at Roche. �Maintenance therapy with MabThera showed unprecedented survival benefits in a serious cancer disease which is currently considered incurable.�
Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam and lead investigator of the pivotal study said: �Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. Maintenance therapy with MabThera may well become the new standard of care for these patients.�
In the EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial, 465 patients with relapsed and refractory indolent NHL were randomised to receive either 3-weekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy or MabThera plus CHOP as induction therapy. Responding patients were then again randomised to either MabThera maintenance, or observation (no further treatment).
The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.
The results of the induction phase of the trial showed that patients who received MabThera and CHOP (R-CHOP) had a significantly higher rate of complete remission than patients who received CHOP chemotherapy alone (29% vs 16%, p value <0 
- The outcome of the clinical trial was presented at the 47th annual meeting of the American Society of Hematology in Atlanta, USA.
www.roche.com
Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
Headquartered in Basel, Switzerland, Roche is one of the world�s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people�s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
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