Health Canada approves KADCYLA™ (trastuzumab emtansine) for the treatment of HER2-positive metastatic breast cancer

Health Canada approves KADCYLA™ (trastuzumab emtansine) for the treatment of 
HER2-positive metastatic breast cancer 
New personalized medicine helped people in Phase III study live longer, with 
less toxicity(i) 
MISSISSAUGA, ON, Sept. 12, 2013 /CNW/ - Roche today announced that Health 
Canada has approved KADCYLA (trastuzumab emtansine or T-DM1), under priority 
review, as a single agent for the treatment of people with HER2-positive 
metastatic breast cancer (mBC) 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.(ii )HER2-positive metastatic breast cancer is a particularly 
aggressive form of the disease. Women with HER2-positive mBC are at an 
increased risk of their disease worsening due to the cancer's hard-to-treat 
KADCYLA is a first in class antibody-drug conjugate (ADC) and is made up of 
three components, an approved monoclonal antibody known as HERCEPTIN 
(trastuzumab), a stable linker, and a potent cytotoxic agent known as DM1. 
KADCYLA targets cancer cells that overexpress the HER2 receptor and, via two 
distinct mechanisms, results in cell cycle arrest or death of cancer cells.(ii) 
According to Dr. Sunil Verma, EMILIA study first author and medical oncologist 
at Sunnybrook's Odette Cancer Centre, KADCYLA represents an important advance 
in the treatment of HER2-positive metastatic breast cancer. He states: 
"KADCYLA specifically targets HER2-positive cancer cells, destroying them 
efficiently and effectively while extending progression-free and overall 
survival. This targeted approach allows for greater efficacy and lowered 
toxicity compared with standard treatment." 
The Health Canada approval of KADCYLA is based on results from the EMILIA 
Study, an open-label, international, and randomized Phase III study comparing 
KADCYLA to lapatinib in combination with XELODA(®) (capecitabine), one of the 
standard treatment options in this setting. EMILIA assessed 991 randomly 
assigned patients with HER2-positive locally advanced or metastatic breast 
cancer who had previously been treated with HERCEPTIN and a taxane 
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) than 
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 less grade 3 or 4 toxicity.(i,ii) 
KADCYLA combines the known antibody trastuzumab (HERCEPTIN) and the potent 
cytotoxic agent, DM1, together using a stable linker, which is designed to 
keep KADCYLA intact until it reaches specific cancer cells to avoid systemic 
toxicity. The antibody (HERCEPTIN) portion binds to the HER2-positive cancer 
cells, and is thought to inhibit cell signaling and activate the body's immune 
system to attack the cancer cells, resulting in cell cycle arrest or cell 
death. In addition, when KADCYLA is absorbed into those cancer cells, it is 
designed to destroy them by releasing the cytotoxic agent. 
Roche has studied ADC science for more than a decade and has eight different 
ADCs in Phase 1 or Phase II studies for different types of cancer. KADCYLA is 
the first ADC resulting from Roche and Genentech's 30 years of HER2 pathway 
research and this promising approach will help deliver more medicines to fight 
other cancers in the future. KADCYLA is the third personalized medicine Roche 
has developed for the treatment of HER2-positive breast cancer, after 
Roche licenses technology for KADCYLA under an agreement with ImmunoGen, Inc. 
About Breast Cancer in Canada
Breast Cancer is the most common cancer diagnosis for women in Canada. 
Accounting for 26 per cent of all cancer cases, it is the second leading cause 
of death in women. On average, 65 women are diagnosed with breast cancer every 
day and it claims the lives of 100 Canadian women every week.(iv ) 
Metastatic (also known as advanced, secondary, or stage IV) breast cancer is 
the spread of cancer cells from the original site where the cancer first 
formed to other parts of the body. It is associated with increased severity 
and is largely incurable.(v,vi )The median survival for a woman with this form 
of breast cancer is two years.(vi) 
Women with HER2-positive breast cancer test positive for a protein called 
human epidermal growth factor receptor (HER2).(vii )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 tumor 
growth and poor clinical outcomes.(vii,viii,ix )One in twenty-nine Canadian 
women will lose their life to the disease.(iv) 
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 
All trademarks used or mentioned in this release are protected by law. 
1. Verma S, et al. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer. N Engl J Med 2012; 367:1783-1791. 
2. KADCYLA Product Monograph.  September XX, 2013. 
3. Mayo Clinic. HER2-positive Breast Cancer. (Accessed March 19, 
4. Canadian Cancer Society. 
5. BC Cancer Agency. (Accessed March 
19, 2013) 
6. Canadian Breast Cancer Network. (Accessed March 
19, 2013) 
7. 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 
8. 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 
9. 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

SOURCE  Roche Canada 
Laura Pagnotta Manager, Corporate Relations Roche Canada 905-542-5853 
To view this news release in HTML formatting, please use the following URL: 
CO: Roche Canada
ST: Ontario
-0- Sep/12/2013 14:49 GMT
Press spacebar to pause and continue. Press esc to stop.