MabThera Receives Positive Opinion in Europe for Combination With Any Chemotherapy Regimen in First-Line Treatment for Follicular Non-Hodgkin's Lymphoma

Basel, Switzerland (ots/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)

Additional information about the Roche Group is available on the
Internet at http://www.roche.com.

All trademarks used or mentioned in this release are legally
protected.

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.

Further Information:

- 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

- Cancer: http://www.health-kiosk.ch/start_krebs.htm

- World Health Organization: http://www.who.int

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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For more information, please contact: Robert Purcell, Roche,
Robert.purcell@roche.com, +41-61-688-0846. Katie Banks, Ketchum,
Katie.Banks@Ketchum.com, +44-207-611-3619