BASEL, Switzerland, December 14 /PRNewswire/ --
- Physicians Will be Able to Prescribe MabThera With Their Preferred Chemotherapy Regimen as Initial Treatment
Roche announced today that the European Union's Committee on Human Medical Products (CHMP) has given a positive recommendation for extension of the MabThera label to include use of MabThera combined with any chemotherapy combination as first-line treatment for follicular Non-Hodgkin's Lymphoma (NHL), the most common form of indolent NHL. Physicians will now be able to prescribe MabThera with their preferred chemotherapy regimen as an initial treatment for their patients.
"The positive opinion is an important step forward in expanding the availability of MabThera as first-line treatment for all patients who could benefit from it," said Manfred Heinzer, Head, Strategic Marketing Oncology at Roche. "It also confirms the dramatic survival benefit to patients observed with MabThera in first-line treatment of indolent NHL and provides further hope for the future treatment of this deadly disease."
The label extension is based on the results of a number of clinical trials that have evaluated the efficacy and safety of MabThera in combination with different chemotherapy regimens. The pivotal study M39021(1), evaluated the combination of MabThera with CVP chemotherapy and formed the basis for the original marketing authorisation in the EU for first-line treatment of follicular lymphoma in 2004. Further results from three randomised trials using MabThera in combination with either CHOP(2), CHVP-I(3) or MCP(4) as the chemotherapy regimen consistently demonstrated a significant improvement in overall survival when compared to chemotherapy alone. Additionally, a meta analysis study(5) focused on first-line treatment of indolent NHL confirmed that MabThera prolonged the life of patients and their time free of disease.
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. NHL is one of the fastest growing cancers and its incidence has grown by 80% since the early 1970s.(6)
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Note to Editors:
1 Marcus R et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105(4):1417-23
2 Hiddemann, W et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomised study of the German Low-Grade Lymphoma Study Group. Blood 2005. 106; 12, 3725-3732.
3 Foussard et al. Update of the FL2000 randomised trial combining rituximab to CHVP-Interferon-alpha in follicular lymphoma (FL) patients (pts). Proc Am Soc Clin Oncol. 2006; 24s: 424a (Abstract 7508).
4 Herold M et al. Rituximab plus mitoxantrone, chlorambucil, prednisolone (RMCP) is superior to MCP alone in advanced indolent and follicular lymphoma - results of a phase III study (OSHO39). Ann Oncol 2005, Abst. 060.
5 Schulz H et al. Combined Immunochemotherapy with Rituximab Improves Overall Survival in Patients with Follicular and Mantle Cell Lymphoma: Updated Meta-Analysis Results. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108 (11): Abst. 2760.
6 World Health Report 2000, World Health Organization, http://www.who.int.
- Roche in Oncology: http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Lymphoma: http://www.lymphoma-net.org
- The Lymphoma Coalition: http://www.lymphomacoalition.org
- World Health Organization: http://www.who.int