Cancer Care Ontario Adds KADCYLA® to the New Drug Funding Program for the Treatment of HER2-Positive Metastatic Breast Cancer

MISSISSAUGA, ON, May 29, 2014 /CNW/ - Women with HER2-positive metastatic breast cancer in Ontario will now be able to access a new treatment option through Cancer Care Ontario (CCO), which has approved the addition of KADCYLA^® (trastuzumab emtansine) to the province's New Drug Funding Program (NDFP) under the Ontario Public Drug Programs (OPDP).  KADCYLA will be funded by CCO as a 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 six months of completing adjuvant therapy with trastuzumab plus chemotherapy.¹

"We are pleased that women in Ontario with HER2-positive metastatic cancer have access to KADCYLA, an important option in treating their disease, through the provincial formulary," said Mr. Ronnie Miller, president and CEO, Roche Canada. "With a proven track record in researching and developing oncology treatments, 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.

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.^2,3  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).⁴  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.^4,5,6 Approximately 5,000 women in Canada are living with this disease.⁷

To date, Ontario, Manitoba, British Columbia and Saskatchewan have funded KADCYLA.

About 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 (trastuzumab) 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.^2,8

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.

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

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.

References
_________________________________

¹   Cancer Care Ontario.  https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=307795 (Accessed May 28, 2014)
²   Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed March 19, 2013)
³   BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed March 19, 2013)
⁴   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
⁵   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
⁶   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
⁷   Tell Her 2 http://tellher2.ca/her2/ (Accessed October 29, 2013)
⁸   Verma S, et al. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer. N Engl J Med 2012; 367:1783-1791.

SOURCE: Roche Canada

Naziah Lasi-Tejani, Roche Canada, 905-542-5555 ext. 4596, [email protected]