Keyword Tag Sort by

Categories: Breast Cancer Herceptin Herceptin IV Herceptin SC Pharmacokinetics Trastuzumab

Roche reports positive study of Herceptin given by subcutaneous injection

Phase III study of a quicker route of administration shows comparable results to intravenous Herceptin

Basel, 18 October 2011-- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III HannaH study demonstrated comparable efficacy of a new, investigational subcutaneous (SC) formulation of Herceptin (trastuzumab) to the standard intravenous (IV) infusion of Herceptin in women with HER2-positive early breast cancer. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

“Herceptin given by subcutaneous injection has the potential to offer patients an effective, more convenient delivery option for this proven medicine,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. “As a leader in innovative treatments for cancer, Roche is committed to a broad research program, including the development of new ways to administer our medicines.”

No new safety signals were observed and adverse events were consistent with Herceptin IV. Data from the study will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union.

About the HannaH study

HannaH is a Phase III, open-label study involving 596 women with HER2 positive early breast cancer. The study was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy and safety of Herceptin SC to that of Herceptin IV.

The study met its co-primary endpoints which were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the study the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count).

About subcutaneous delivery

Herceptin SC uses Enhanze™ Technology, developed by Halozyme Therapeutics, Inc. which enables the injection of large volumes of a medication under the skin (subcutaneous). It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.

About Herceptin

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. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumour. The initial loading dose for IV Herceptin should be administered as a 90 minute infusion. If the initial loading dose is well tolerated, the subsequent doses can be administered as a 30-minute infusion. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer as well as HER2-positive advanced (metastatic) stomach cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve disease-free survival overall survival and response rates while maintaining quality of life in people with HER2-positive breast and stomach cancer. 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 almost one million patients with HER2-positive breast and stomach cancer worldwide and is approved in more than 150 countries.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 people will die of the disease annually.1

In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumour cells. This is known as ‘HER2 positivity’ and affects approximately 15-20 percent of people with breast cancer.2

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

All trademarks used or mentioned in this release are protected by law.

1) Ferlay J, et al. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10. Lyon, France: International Agency for Research on Cancer; 2010. Available from:
2) Wolff A.C et al American Society of Clinical Oncology/ College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med—Vol 131, January 2007
Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

Contact: Roche Group Media Relations, Corporate Communications, CH-4070 Basel, Switzerland, Tel: +41-61-688 8888, Fax: +41-61-688 2775, Send E-Mail

Source:  Roche, F. Hoffmann-La Roche Ltd

Related News:

Stem Cells for Metastasis Found in Blood of Breast Cancer Patients 30 April 2013, 08:43
For the first time, scientists from the German Cancer Research Center (DKFZ) and the National...

Less Invasive Treatment is Associated with Improved Survival in... 28 January 2013, 09:03
DURHAM, N.C. -- Patients with early stage breast cancer who were treated with lumpectomy plus...

Diverse Genetic Alterations Found in Triple-negative Breast Cancers... 7 December 2012, 06:01
Residual tumor cells are found in up to 70 percent of these patients. Multiple types of...

Combination therapy with experimental drug improves outlook for... 5 December 2012, 08:08
A combination therapy using an experimental new drug shows significant promise for women with a...

New Insights on Control of Pituitary Hormone Outside of Brain has... 2 October 2012, 04:23
PHILADELPHIA — The hormone prolactin is produced by the pituitary gland in the brain and then...

Comprehensive genomic analysis sheds new light on subtypes of... 24 September 2012, 10:23
HOUSTON -- (September 24, 2012) -- Comprehensive genomic analysis of breast tumors revealed four...

Study reveals genomic similarities between breast cancer and... 24 September 2012, 03:19
UCSC bioinformatics team makes important contributions to breast cancer study from The Cancer...

Protein Linked to Therapy Resistance in Breast Cancer 12 September 2012, 04:26
Berkeley Lab Researchers Identify Possible New Oncogene and Future Therapy Target.A gene that may...

TRPM7 Protein Key to Breast Cancer Metastasis in Animal Models 11 August 2012, 12:48
In a mouse xenograft model, TRPM7 drives breast cancer cell metastasis. Class of proteins...

Novartis drug Afinitor® approved by European Commission to treat... 30 July 2012, 11:59
In combination with exemestane, Afinitor is approved for use in women with HR+/HER2-...