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Herceptin
receives positive opinion in Europe for early use in HER2-positive
breast cancer
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Basel,
28 April 2006
Important step towards broad access of Herceptin
for women with aggressive form of breast cancer
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Herceptin: a medicine to treat breast cancer
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Roche today
announced that the European Union’s Committee for Human Medicinal
Products (CHMP) has issued a positive recommendation for the use
of Herceptin following surgery and standard chemotherapy as adjuvant
treatment of early-stage HER2-positive breast cancer. HER2-positive
breast cancer, which affects approximately 20% – 30%1
of women with breast cancer, demands special and immediate attention
because the tumours are fast-growing and there is a higher likelihood
of relapse.
The CHMP’s decision is based on impressive results from the international
HERA (HERceptin Adjuvant) study which showed Herceptin following
standard chemotherapy significantly reduces the risk of cancer
coming back by 46% compared to chemotherapy alone.2 These remarkable benefits have
also been seen in three other major global and US studies.3
“The results from four large-scale trials speak for themselves:
Herceptin consistently reduces the risk of relapse when used in
early stages, providing the best chance of long-term survival
to women with an extremely aggressive form of breast cancer,”
commented Ed Holdener, Head of Roche’s Global Pharma Development.
“The CHMP’s timely decision represents a significant milestone,
bringing patients and the medical community one step closer to
broadly accessing this effective therapy in the EU.”
The positive opinion will now be proposed for approval by the
European Commission. Herceptin is the only approved therapy specifically
for the treatment of metastatic (advanced) HER2-positive disease,
so the new approval will allow Herceptin to be used following
surgery for early-stage breast cancer, as ‘adjuvant’ therapy.
In the US, Genentech filed a supplemental Biologic License Application
(sBLA) for the use of Herceptin in early-stage HER2-positive breast
cancer with the Food and Drug Administration (FDA) on February
15th, 2006. The application is based on data from the combined
interim analysis of two large US trials,4
and Genentech has received a priority review designation.
About the HERA study
HERA, conducted by the Roche and Breast International Group (BIG),5
is one of the largest adjuvant studies ever carried out among
breast cancer patients; enrolment to the trial began in December
2001, and nearly 5,100 HER2-positive patients were enrolled at
480 sites in 39 countries across the world. HERA is a randomised
trial, which, following standard adjuvant systemic chemotherapy
and radiotherapy (if applicable), evaluates observation versus
Herceptin every three weeks for 12 months or 24 months in women
with early-stage HER2-positive breast cancer. The HERA study allowed
for the use of a wide range of chemotherapy regimens, and both
lymph node-positive and lymph node-negative patients were eligible
for entry into the trial.
According to the interim analysis, the primary efficacy endpoint
was met, showing that in the 12-month arm, patients who received
Herceptin had a statistically significant improvement in disease-free
survival (the length of time after treatment during which no disease
is found). At a median follow-up of one year, the secondary endpoint
of overall survival had not reached statistical significance,
but showed a clear trend towards an improvement in overall survival,
which is to be confirmed as the data mature.
The interim analysis compared Herceptin versus observation and
did not include a comparison of 12 months versus 24 months treatment
duration. The trial will continue to assess this comparison and
data will become available in due time as the study matures.
The HERA study has an external Independent Data Monitoring Committee
(IDMC) that regularly reviews safety data. No safety concerns
were raised by the IDMC, and the incidence of congestive heart
failure was very low (0.5% in the Herceptin arms vs. 0% in the
observation arm). Patients in this study will continue to be followed
for any side effects.
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during
their lifetime, making it one of the most common types of cancer
in women.6 Each year more
than one million new cases of breast cancer are diagnosed worldwide,
with a death rate of nearly 400,000 people per year.
In HER2-positive breast cancer, increased quantities of the HER2
protein are present on the surface of the tumour cells. This is
known as ‘HER2 positivity.’ High levels of HER2 are present in
a particularly aggressive form of the disease which responds poorly
to chemotherapy. Research shows that HER2-positivity affects approximately
20-30% of women with breast cancer.
Herceptin is a humanised antibody, designed to target and block
the function of HER2, a protein produced by a specific gene with
cancer-causing potential. In addition to its efficacy in the early-stage
breast cancer setting, Herceptin also has demonstrated improved
survival in the advanced (metastatic) setting, where its addition
to chemotherapy allows patients to live up to one-third longer
than chemotherapy alone.7
Herceptin received approval in the European Union in 2000 for
use in patients with metastatic breast cancer, whose tumours overexpress
the HER2 protein. In addition to being indicated for use in combination
with docetaxel as a first-line therapy in HER2-positive patients
who have not received chemotherapy for their metastatic disease,
it is also indicated as a first-line therapy in combination with
paclitaxel where anthracyclines are unsuitable, and as a single
agent in third-line therapy. Herceptin is marketed in the United
States by Genentech, in Japan by Chugai and internationally by
Roche. Since 1998, Herceptin has been used to treat over 230,000
HER2-positive breast cancer patients worldwide.
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 (http://www.roche.com/).
All trademarks used or mentioned
in this release are legally protected.
Additional information:
- About Genentech
- Roche
in Oncology
- Roche Health Kiosk on cancer
- Video
clips - in broadcast standard, free of charge
References:
1 Harries M, Smith I. The development and clinical use of
trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
2 Piccart-Gebhart M, Procter M, Leyland-Jones B, et al.
A Randomized Trial of Trastuzumab Following Adjuvant Chemotherapy
in Women with HER2 Positive Breast Cancer. New England Journal
of Medicine 353:16 2005.
3 NCCTG N9831 (US), NSABP B-31 (US), BCIRG 006 (international)
4 Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant
Chemotherapy for Operable HER2 Positive Breast Cancer. New England
Journal of Medicine 353:16 2005.
5 Collaborative partners for the HERA study include: Roche,
BIG and its affiliated collaborative groups, plus non-affiliated
collaborative groups, and independent sites.
6 World Health Organization, 2000.
7 Extra JM, Cognetti F, Maraninchi D et al. Long-term survival
demonstrated with trastuzumab plus docetaxel: 24-month data from
a randomised trial (M77001) in HER2-positive metastatic breast
cancer. Abstract #555, American Society for Clinical Oncology
(ASCO) Annual Meeting 2005.
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