BC Cancer Agency Adds PERJETA®-HERCEPTIN® Combo Pack for Treatment of HER2-Positive Metastatic Breast Cancer to the Provincial Formulary

MISSISSAUGA, ON, Dec. 2, 2013 /CNW/ - People 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 PERJETA to the BCCA Drug Benefit Listing.  The regimen of pertuzumab (PERJETA) and trastuzumab (HERCEPTIN) in combination with docetaxel is given every three weeks for the first‐line treatment of metastatic HER2‐positive breast cancer continuing until disease progression or toxicity after docetaxel completion.1

"We're pleased the BC Cancer Agency has added the PERJETA-HERCEPTIN Combo Pack to the provincial formulary, giving patients with HER2-positive metastatic breast cancer in BC access to a new treatment option in the fight against the disease," said Mr. Ronnie Miller, president and CEO, Roche Canada. "For more than a decade, Roche has been committed to improving breast cancer treatment through innovative research and development and we are very proud to be expanding our offering and to continue to provide more treatment options."

In Canada, breast cancer is the most commonly diagnosed cancer in women.2  It accounts for 26 per cent of all cancer cases, making it the second leading cause of death in women.1 On average, 3,100 women in BC are diagnosed with breast cancer every year.3

Metastatic (also known as advanced, secondary or stage IV) breast cancer, the spread of cancer cells from the original site where the cancer first formed to other parts of the body, is associated with increased severity and is largely incurable.4,5 The median survival for a woman with this form of breast cancer is two years.4

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor (HER2).6 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. 5,7,8 Approximately 5,000 women in Canada are living with this disease.9

British Columbia was the first province to fund the PERJETA-HERCEPTIN Combo Pack.

About PERJETA
PERJETA (pertuzumab), in combination with the current standard of care, HERCEPTIN® (trastuzumab) and docetaxel chemotherapy, is approved by Health Canada for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.10

The Health Canada approval of PERJETA is largely based on the phase III CLEOPATRA trial.  In the trial, people who received a combination of PERJETA, HERCEPTIN and docetaxel chemotherapy, lived a median 6.1 months longer without their cancer getting worse (progression-free survival) compared with the standard of care, HERCEPTIN plus docetaxel chemotherapy, alone (median PFS 18.5 versus 12.4 months ; HR=0.62; p<0.0001).9,11  Further, the combination of PERJETA, HERCEPTIN and docetaxel chemotherapy significantly extended the lives of people with previously untreated HER2-positive metastatic breast cancer (overall survival) compared to HERCEPTIN, docetaxel chemotherapy and placebo.  The risk of death was reduced by 34 per cent for people on the PERJETA arm of the study, compared to those who received HERCEPTIN and docetaxel chemotherapy alone (HR=0.66; p=0.0008).12  At the time of the data analysis, median overall survival had not yet been reached because more than half of the patients receiving the PERJETA combination were still alive.11 The combination of PERJETA, HERCEPTIN and chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.

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, infectious diseases, inflammation, metabolism 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 personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 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.

References

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1 BC Cancer Agency.  http://www.bccancer.bc.ca/HPI/ChemotherapyProtocols/stupdate.htm (Accessed November 13, 2013)
2 Canadian Cancer Society. http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on (Accessed October 29, 2013)
3 Canadian Breast Cancer Foundation.  http://www.cbcf.org/central/AboutBreastCancerMain/AboutBreastCancer/Pages/BreastCancerinCanada.aspx (Accessed November 4, 2013)
4 Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed March 19, 2013)
5 BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed March 19, 2013)
6 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
7 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
8 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
9 Tell Her 2 http://tellher2.ca/her2/ (Accessed October 29, 2013)
10 PERJETA™ Product Monograph.  April 12, 2013.  Hoffmann-La Roche Limited.
11 Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012; 366:109-110.
12 Swain S, et al. Confirmatory overall survival analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled Phase III study with pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive first-line metastatic breast cancer. Poster presented at the 2012 CTRC-AARC San Antonio Breast Cancer Symposium. Abstract # P5-18-26.


SOURCE: Roche Canada

For further information:


Jane McCoubrey
Director, Corporate Relations
Roche Canada
905-542-5535
jane.mccoubrey@roche.com


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