ERBITUX® in combination with chemotherapy approved in Canada as initial treatment of patients with metastatic colorectal

ERBITUX® in combination with chemotherapy approved in Canada as initial 
treatment of patients with metastatic colorectal cancer 
First new biologic treatment regimen approved in eight years for newly 
diagnosed patients with metastatic colorectal cancer 
MONTREAL, Jan. 14, 2013 /CNW/ - Bristol-Myers Squibb Canada is pleased to 
announce that Health Canada has approved ERBITUX(® )(cetuximab)( )as an 
initial treatment option for Canadians with metastatic colorectal cancer 
whose tumours have a non-mutated KRAS gene. 
Erbitux is a biomarker-directed therapy that was initially approved in Canada 
in 2008 for the treatment of epidermal growth factor receptor 
(EGFR)-expressing metastatic colorectal cancer for patients whose disease 
progressed after chemotherapy. The new Health Canada approval allows Erbitux 
for use as an initial therapy in combination with the chemotherapy regimen 
FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for patients with non-mutated 
KRAS (commonly known as KRAS wild-type), epidermal growth factor receptor 
(EGFR)-expressing metastatic colorectal cancer (mCRC). 
"We are learning more about important biological distinctions in metastatic 
colorectal cancer and that different profiles of the disease can respond in 
different ways to treatments," said Dr. Derek Jonker, an oncologist at the 
Ottawa Hospital Cancer Centre. "This approval gives us an important new 
treatment option for newly diagnosed patients of KRAS wild-type status. It is 
another encouraging step forward in our ability to treat this very serious 
The approval is based on data from the CRYSTAL (Cetuximab combined with 
iRinotecan in first-line therapY for metaSTatic colorectAL cancer) trial, a 
European Phase 3 open-label, randomized, multicentre study with 
progression-free survival (PFS) as the primary endpoint comparing patients 
treated with Erbitux (cetuximab) plus FOLFIRI (the CRYSTAL regimen) versus 
FOLFIRI alone. 
Bristol-Myers Squibb Canada will work with health authorities to ensure that 
patients in Canada with metastatic colorectal cancer who may benefit from 
Erbitux will have access to it. 
CRYSTAL study key findings
CRYSTAL data showed that adding cetuximab to FOLFIRI vs. FOLFIRI alone 
significantly prolonged PFS and significantly enhanced tumor response in the 
first-line treatment of metastatic colorectal cancer in patients with KRAS 
wild-type tumors: median PFS: 9.9 versus 8.4 months (HR=0.70; p=0.0012; median 
OS: 23.5 vs. 20.0 mo (HR=0.80; p=0.0093); Response Rate (RR): 57.3% vs. 39.7% 
About colorectal cancer in Canada
Based on the latest available statistics, an estimated 23,300 people in Canada 
were diagnosed with colorectal cancer in 2012, including 13,000 men and 10,300 
women. It is the third-most diagnosed cancer, behind only prostate and lung 
cancer, accounting for 13 per cent of all new cancer cases in Canada last 
year. It is estimated it that colorectal cancer will have caused 9,200 deaths 
in Canada in 2012, making it the second leading cause of cancer deaths in the 
country and accounting for 12 per cent of all cancer deaths. In 2011, the 
five-year relative survival for colorectal cancer in Canada was 63%. 
About the KRAS gene
KRAS stands for Kirsten Rat Sarcoma gene, which was first isolated in 1967. 
KRAS (pronounced kay-razz) is a gene present in cancer tumours that plays an 
important role in their growth and development. Non-mutated KRAS is called 
wild-type KRAS. Mutated versions have been detected in various cancers, 
including in about 40 per cent of persons with colorectal cancer. Anti-EGFR 
therapy, including Erbitux, is not effective in tumours with the KRAS 
mutation. The presence of KRAS mutation or not is determined by a laboratory 
test performed on tissue from the cancer tumour removed during surgery. 
About Erbitux
Erbitux( )(cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit 
the function of a molecular structure expressed on the surface of normal and 
tumor cells called the epidermal growth factor receptor (EGFR, HER1, 
c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding 
of cetuximab to the EGFR blocks phosphorylation and activation of 
receptor-associated kinases, resulting in inhibition of cell growth induction 
of apoptosis (cell death), and decreased matrix metalloproteinase and vascular 
endothelial growth factor production. Signal transduction through the EGFR 
results in activation of KRAS wild-type protein. However, in cells with 
activating KRAS somatic mutations, the mutant KRAS protein is continuously 
active and appears independent of EGFR regulation. In vitro, cetuximab can 
mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human 
tumor types. In vitro assays and in vivo animal studies have shown that 
cetuximab inhibits the growth and survival of tumor cells that express the 
EGFR. No anti-tumor effects of cetuximab were observed in human tumor 
xenografts lacking EGFR expression. 
Erbitux is also approved in Canada for the initial treatment of locally or 
regionally advanced squamous cell carcinoma of the head and neck in 
combination with radiation therapy. 
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of 
Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission 
is to discover, develop and deliver innovative medicines that help patients 
prevail over serious diseases. Bristol-Myers Squibb Canada is a leading 
provider of medicines to fight cancer, cardiovascular and metabolic disorders, 
infectious diseases (including HIV/AIDS), nervous system diseases and serious 
mental illness. Bristol-Myers Squibb Canada's operations are headquartered in 
Montreal, Quebec. 
Erbitux is a registered trademark of ImClone LLC. 
Monica Flores Senior Manger, Corporate and Business Communications 
Bristol-Myers Squibb Canada 514-333-3845 
SOURCE: Bristol-Myers Squibb Canada 
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-0- Jan/14/2013 14:00 GMT
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