Investor Update
Basel, 11 July 2006 1
MabThera
approved in Europe for maintenance therapy in patients with common form of lymphoma
Life-saving
medicine reduces the risk of death by almost half
Roche announced today
that the European Commission has approved MabThera (rituximab) as maintenance therapy for patients with
relapsed or refractory follicular Non-Hodgkin’s Lymphoma (NHL), the most common form of indolent NHL.
MabThera maintenance therapy reduces the risk of death by almost half (48%) for patients with this form
of NHL, compared to standard disease management.
NHL is one of the fastest
growing cancers and has grown in incidence by 80% since the early 1970s.
“Maintenance
therapy with MabThera is the first treatment in 30 years that prolongs the life of these patients to
such an extent,” said William M. Burns, CEO Division Roche Pharma “The quick approval of MabThera maintenance
therapy mirrors the dramatic survival benefit this medicine can bring to the patient providing new hope
to control the disease.”
MabThera was previously approved in the EU for
first-line treatment of both aggressive and indolent NHL (in combination with chemotherapy) and as a
second-line monotherapy for indolent NHL. This new indication gives patients with relapsed follicular
NHL a better chance to live disease- free for longer, allowing them up to an additional 3 years without
new chemotherapy treatments.
Label Extension Based On
Pivotal Study
The label extension is based on the impressive results of the EORTC
(European
Organisation for Research and Treatment of Cancer) 20981 study, performed in 18 countries worldwide,
that was presented at the 47th annual conference of the American Society of Hematology in Atlanta in
December 2005. For more details on the study design and results, see the ‘further information’ section
at the end of this release.
About MabThera
MabThera
is
a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal
and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells.
Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate
after treatment and return to normal levels within several months.
MabThera
is indicated for the treatment of indolent and aggressive Non-Hodgkin’s Lymphoma. To date, patients
have received more than 730,000 treatments with MabThera worldwide.
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.
About
Roche
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
2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division
posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has
R&D agreements and strategic alliances with numerous partners, including majority ownership interests
in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Additional Information
- Information on the pivotal study EORTC 20981
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
1
World Health Report 2000, World Health Organization, www.who.int.