Today's announcement is heralded by the Colorectal Cancer Association of Canada as a "bold step towards personalized medicine" in colorectal cancer treatment for Ontarians.  

   "Colorectal Cancer is the second biggest cancer killer in the country, with approximately 8,000 of the 21,500 Canadians being diagnosed this year alone in Ontario," said Barry Stein, president of the Colorectal Cancer Association of Canada. "We are pleased to see Ontario take a leading role in providing patients with access to Vectibix(TM). This class of therapy represents the future of cancer treatment. Timely and equal access to effective treatments such as Vectibix(TM) is essential to prolong the lives of patients with advanced disease. It is therefore important that all provinces recognize these new advances and demonstrate a similar commitment to treating colorectal cancer patients," he added.

    The Ministry of Health and Long Term Care (MOHLTC) announced funding for Vectibix(TM) through Cancer Care Ontario's New Drug Funding Program, following a positive recommendation from Ontario's Committee to Evaluate Drugs, an expert advisory body which provides advice to the province around the funding of drugs.

    A disease that affects the digestive system, colorectal cancer is the third most common cancer worldwide, with nearly one million people diagnosed every year.(1) Although colorectal cancer is the second leading cause of cancer death in Canada,(2) it is more than 90 per cent preventable.(3) Yet, for many patients, the cancer is detected once it has already spread to other parts of the body.(4)

    "You can't imagine what it is like to be told you have cancer - cancer that has already begun to spread," said Alvin Jessop, a resident of Barrie, Ontario and father of two teenagers. Alvin was diagnosed with metastatic colorectal cancer at age 50, after his family doctor convinced him to have his first colonoscopy. "When my doctor told me about Vectibix(TM) and determined that I was a candidate for this therapy through a clinical trial, I started to feel hope again. Twelve months after starting therapy, I feel healthy and I'm able to enjoy spending time with my wife, children, family and good friends. Vectibix(TM) is the reason I'm alive today."

    Vectibix(TM), which received a Notice of Compliance with Conditions by Health Canada in April 2008, is an important treatment option for colorectal cancer patients following standard chemotherapy regimens. As monotherapy, Vectibix(TM) has been shown to significantly reduce the chance that certain patients' metastatic colorectal cancer would continue to grow. As a fully human monoclonal antibody, Vectibix(TM) offers an effective targeted therapy with a low risk of the body reacting adversely to the infusion. Vectibix(TM), at a dose of 6mg/kg, is administered via infusion once every two weeks.(5)

    Vectibix(TM) works by recognizing a protein in the body known as epidermal growth factor receptor (EGFr), which is over expressed on the surface of some cancer cells. When growth factors (other body proteins) attach to the EGFr, the cell is stimulated to grow and divide. Vectibix(TM) binds to the EGFr and prevents the highly active cancer cell from receiving the messages it needs for growth and division.(6)

    In patients whose tumours have a mutation in a gene called KRAS, cancer cells continuously receive messages to grow and divide despite anti-EGFr treatment. These patients do not respond to anti-EGFr therapy.(7) It is important to detect the mutated gene so the right treatment can be prescribed. KRAS analysis provides guidance in therapeutic treatment decisions for patients with metastatic colorectal cancer.

    KRAS testing can be performed at several pathology laboratories across Canada. Mount Sinai Services has been designated by MOHLTC to conduct K-RAS testing for patients who may be eligible to receive Vectibix(TM). Amgen Canada is currently funding KRAS testing for patients who may be eligible to receive Vectibix(TM) at Mount Sinai Services and St Michael's Hospital in Toronto, Ontario.

    Vectibix(TM) is the first and only treatment for metastatic colorectal cancer to contain data in its label that shows how to predict which patients most likely will not benefit from treatment. By knowing a patient's KRAS mutation status, healthcare professionals are better able to determine whether a person might benefit from Vectibix(TM) treatment and target appropriate cancer therapy for their patients.(8) By focusing on patients who do not have the mutated KRAS gene, scarce resources are directed towards patients who will have the greatest chance of benefiting from the treatment.

    "Mutant KRAS is detected in approximately 40 per cent of colorectal cancer tumours," said Dr. Ronald Burkes, medical oncologist, Mount Sinai Hospital in Toronto. "This means that Vectibix(TM) has the potential to benefit 60 per cent of patients with metastatic colorectal cancer. Today's announcement means hope for a significant number of people living with colorectal cancer in Ontario. Vectibix(TM) is an important treatment option for metastatic colorectal cancer, a disease that kills so many Canadians ayear."

    About Amgen Canada

    Amgen Canada applies science and innovation to help fight serious illness and dramatically improve people's lives. With Canadian headquarters located in Mississauga's vibrant biomedical cluster, and a research facility in Burnaby, British Columbia, Amgen's Canadian affiliate has been an important contributor to Canada's biotechnology sector since 1991. Amgen Canada serves patients throughout Canada by delivering vital medicines to them. In addition, Amgen contributes to the development of new therapies or new uses for existing medicines in partnership with many of Canada's leading healthcare, academic, research, government, and patient organizations. Today, tens of thousands of Canadians use Amgen medicines every year, and thousands more are enrolling in Amgen clinical studies to deliver the next generation of innovation.

    (1) Mount Sinai Hospital Web site:  
          http://www.mountsinaiservices.com/K-ras/default.htm
    (2) Colorectal Cancer Association of Canada Web site: 
          http://www.colorectal-cancer.ca/en/just-the-facts/colorectal/   
    (3) Colorectal Cancer Association of Canada Web site:
          http://www.colorectal-cancer.ca/en/screening/screening-tests/
    (4) US National Cancer Institute Web site:
          http://seer.cancer.gov/statfacts/html/colorect.html   
    (5) Vectibix(TM) Product Monograph
    (6) Ibid. 
    (7) Mount Sinai Hospital Web site:
          http://www.mountsinaiservices.com/K-ras/default.htm 
   (8) Amado RG, Wolf M, Peeters M et al. Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients
         With Metastatic Colorectal Cancer J Clin Oncol 2008;26:1626-1634.           
         http://jco.ascopubs.org/cgi/content/abstract/26/10/1626

For further information: Kate Hanna, Senior Consultant, GCI Group, (416) 486-5907, khanna@gcigroup.com; Naz Araghian, Consultant, GCI Group, (416) 486-7225, naraghian@gcigroup.com; Sabrina Paiva, Senior Manager, Product PR and Stakeholder Relations, Amgen Canada, (905) 285-3145, spaiva@amgen.com