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
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.
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. www.bmscanada.ca.
Erbitux is a registered trademark of ImClone LLC.
Monica Flores Senior Manger, Corporate and Business Communications
Bristol-Myers Squibb Canada 514-333-3845 firstname.lastname@example.org
SOURCE: Bristol-Myers Squibb Canada
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-0- Jan/14/2013 14:00 GMT
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