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 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

Monica Flores
Senior Manger, Corporate and Business Communications
Bristol-Myers Squibb Canada
514-333-3845 
[email protected]