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 cancer."
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% (p<0.001).
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. www.bmscanada.ca.
Erbitux is a registered trademark of ImClone LLC.
SOURCE: Bristol-Myers Squibb Canada
