BC Cancer Agency Adds KADCYLA® to the Provincial Formulary for the Treatment of HER2-Positive Metastatic Breast Cancer

MISSISSAUGA, ON, May 8, 2014 /CNW/ - Women with HER2-positive metastatic breast cancer in British Columbia will now be able to access a new treatment option through the BC Cancer Agency.  The BC Cancer Systemic Therapy Program has approved the addition of KADCYLA® (trastuzumab emtansine) to be added to the BCCA Drug Benefit Listing. KADCYLA has been approved as second line treatment for patients with HER2-positive, unresectable locally advanced or metastatic breast cancer, who have received prior treatment with HERCEPTIN® (trastuzumab) plus chemotherapy in the metastatic setting or have disease recurrence during or within 6 months of completing adjuvant therapy with trastuzumab plus chemotherapy.1

"We're pleased British Columbia has added KADCYLA to the provincial formulary, giving patients with HER2-positive metastatic breast cancer in the province access to an important option to treat their disease," said Mr. Ronnie Miller, president and CEO, Roche Canada. "Roche has a long history of research and development in oncology, and we are proud to offer a new and targeted way of treating HER2-positive breast cancer." 

KADCYLA is the first approved antibody drug conjugate for treatment of HER2-positive metastatic breast cancer in Canada. It is made up of three components: an antibody called HERCEPTIN® (trastuzumab), a stable linker, and a cytotoxic agent called DM1.  KADCYLA works by targeting and destroying cancer cells, resulting in increased survival and fewer grade 3 or 4 side effects for patients.2

Metastatic breast cancer (also known as advanced, secondary or stage IV), which is the spread of cancer cells from the original site where the cancer first formed to other parts of the body, is largely incurable.3,4  The median survival for a woman with metastatic breast cancer is two years.4  

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor (HER2).5  This protein is found in high quantities on the outside of HER2-positive breast cancer cells.  HER2-positive breast cancer represents approximately 10 to 20 per cent of human cancers, and without treatment, it is associated with aggressive tumour growth and poor clinical outcomes.5,6,7 Approximately 5,000 women in Canada are living with this disease.8

To date, British Columbia and Saskatchewan have funded KADCYLA.


KADCYLA (trastuzumab emtansine) is approved by Health Canada as a single agent for the treatment of people with HER2-positive metastatic breast cancer who received both prior treatment with HERCEPTIN and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.2

The Health Canada priority review approval of KADCYLA is largely based on the phase III EMILIA trial.  In the trial, people who received KADCYLA had a median Overall Survival (OS) improvement of 5.8 months (HR=0.682, p=0.0006; median OS 30.9 months versus 25.1 months) versus those who received the combination of lapatinib and XELODA.  Study findings also showed that people who received KADCYLA had significantly longer Progression Free Survival (PFS) (HR=0.650, p<0.0001; median PFS 9.6 months vs. 6.4 months) with an overall decrease in grade 3 or 4 toxicities.2,9

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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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Disclaimer:  Cautionary statement regarding forward-looking statements
This document may contain certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche's earnings or earnings per share for any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.


1 http://www.bccancer.bc.ca/NR/rdonlyres/4478D9DB-662B-43C2-8839-6D3C374D3FAE/69985/STUpdateMay2014_Final.pdf
2 KADCYLA Product Monograph.  September 2013
3 Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed April 29, 2014)
4 BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed April 29, 2014)
5 Chia et al. Human Epidermal Growth Factor Receptor 2 Overexpression As a Prognostic Factor in a Large Tissue Microarray Series of Node-Negative Breast Cancers, Journal Of Clinical Oncology. 2008;26:5697-5700
6 Ross et al. The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine, The Oncologist. 2009;14:320-368
7 Wolff 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 Patho Lab Med 2007;101:18-43
8 Tell Her 2 http://tellher2.ca/her2/ (Accessed April, 2013)
9 Verma S, et al. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer. N Engl J Med 2012; 367:1783-1791.

SOURCE: Roche Canada

For further information: Jane McCoubrey, Roche Canada, 905-542-5535, jane.mccoubrey@roche.com

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