Basel, 29 February 2008
Herceptin approved in Japan for early treatment in patients with HER2-positive breast cancer
Life-saving standard of care treatment Herceptin now available worldwide
Roche announced today that its majority-owned subsidiary Chugai Pharmaceutical Co. Ltd received approval from the Japanese Health Authority for the use of Herceptin in the early treatment for women with HER2-positive breast cancer. The approval was based on the impressive HERA (HERceptin Adjuvant) study results demonstrating that Herceptin significantly reduced the risk of death and recurrence by more than one third(34% and 36% respectively), in women with HER2-positive early-stage breast cancer when given following surgery and standard chemotherapy. 1
“It is most rewarding to see that Herceptin has improved the outlook for women with HER2-positive breast cancer in such a remarkable way and that its exceptional benefits are being recognised by health authorities across the world”, commented William M. Burns, CEO of Roche’s Pharmaceuticals Division. “We hope that all Japanese women suffering from this devastating disease will now be able to have access to Herceptin, a treatment that has been proven to offer the best chance for a cure.”
HER2-positive breast cancer affects approximately 20% to 30%2 of women with breast cancer.
Prior to Herceptin, these patients had a particularly poor outlook because of the aggressive nature of their HER2-positive cancer. Based on a meta-analysis of results from randomized studies, it is estimated that Herceptin reduces the number of women who are at risk of their disease coming back within 10 years after diagnosis by about half, from 37% to 18%.3 This means that Herceptin has the potential to change the course of the disease resulting in a much more positive outlook for all women with HER2-positive disease.
Prof. Masakazu Toi, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan commented, “The diagnosis of early HER2-positive breast cancer is no longer seen as a death-sentence as Herceptin reduces the risk of recurrence by about half. It’s exciting that Herceptin is considered the standard of care for HER2-positive breast cancer patients around the world”.
Evidence that Herceptin benefits patients with HER2-positive breast cancer across all stages of the disease continues to mount, with more than 450,000 patients worldwide treated and a huge clinical study programme ongoing that includes women with early breast cancer, women with advanced (metastatic) breast cancer and women who need further treatment when their disease comes back.
About the HERA study
HERA, conducted by the Roche and Breast International Group (BIG) 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 two years, the secondary endpoint of overall survival showed a clear trend towards an improvement, which is to be confirmed as the data analysis proceeds.
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
Breast cancer is the most common cancer among women worldwide.4 Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.5
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 percent of women with breast cancer.
About Herceptin (trastuzumab)
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. It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.
Herceptin received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.
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 about 450,000 HER2-positive breast cancer patients worldwide.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.
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1. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomized controlled trial. Lancet 369: 29 2007
2. Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
3. Viani et al., Adjuvant trastuzumab in the treatment of HER-2-positive early breast cancer: a meta-analysis of published randomized trials. BMC Cancer 2007, 7:153; and Roche database
4. World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
5. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004