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SMC recommends Erbitux for use in the first line treatment of metastatic bowel cancer patients in Scotland

Erbitux (cetuximab), in combination with FOLFIRI or FOLFOX, has been recommended for use within NHS Scotland by the Scottish Medicines Consortium (SMC) for the first line treatment of metastatic bowel cancer, a disease which affects over 4,000 new patients in Scotland each year.1,2 The treatment will be available to those patients who have the RAS wild type biomarker, which is present in approximately 50% of all bowel cancer patients.3 No other monoclonal antibodies were previously recommended in this setting.

Bowel cancer is the third most commonly diagnosed cancer for both men and women and is the second most common cause of cancer death with around 1,600 people dying each year in Scotland.4 Bowel cancer is a major health problem with Scotland having a higher rate of bowel cancer than most other countries in the Western world.4

Dr Janet Graham, Consultant Oncologist, Beatson Institute, Glasgow, said: “We welcome this decision from the Scottish Medicines Consortium to recommend Erbitux in combination with chemotherapy for further funding in Scotland for all RAS wild type metastatic bowel cancer patients.”

“This positive recommendation is great news for clinicians, patients and their families alike in Scotland. This is a treatment that has a proven survival benefit in these bowel cancer patients which highlights the importance of biomarker testing to ensure that patients can receive personalised treatments based on their biomarker status.”

The SMC’s recommendation was based on detailed analysis of the clinical and cost- effectiveness data of Erbitux in the first line setting for metastatic bowel cancer patients with RAS wild-type tumours.1 The panel recommended that Erbitux should be funded in Scotland due to the clinical benefit for patients and because no other monoclonal antibodies are currently available first line. The submission was supported by clinical experts and Bowel Cancer charities.1

David Garmon-Jones, General Manager at Merck Serono UK, said: “At Merck Serono we are committed to developing personalised treatments which can benefit patients based on their biomarker status to best inform their treatment decisions and eventual outcomes. Therefore, we welcome the Scottish Medicines Consortium decision to further fund Erbitux in Scotland for metastatic patients with RAS wild type metastatic bowel cancer in the first line setting.”

Erbitux has previously been recommended by the SMC for RAS wild type metastatic colorectal cancer with metastases that are confined only to the liver.5

About Bowel Cancer

Bowel cancer is the fourth most common cancer in the UK and the second most common cause of cancer death in the UK after lung cancer.6 In the UK, more than 41,500 patients are diagnosed with bowel cancer each year which equates to more than 110 people per day.6 More than 22,000 new cases are diagnosed with late-stage or metastatic bowel cancer.7

Erbitux

Erbitux® is a first-in-class IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal- transduction pathway.

Erbitux has already obtained market authorisation in over 90 countries for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN).

Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialise Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

Please consult the Erbitux (cetuximab) Summary of Product Characteristics (SPC) for more information. Available at www.medicines.org.uk/emc/.

Source

1 Scottish Medicines Consortium announcement. January 2015

2 NHS Scotland. Bowel Screening Programme. Available at http://www.bowelscreening.scot.nhs.uk/. Last accessed December 2014

3 Erbitux (cetuximab) Summary of Product Characteristics (SPC) http://www.medicines.org.uk/emc/medicine/19595. Last accessed December 2014

4 ISD Scotland. Bowel Cancer in Scotland. Available at http://www.isdscotland.org/Health-Topics/Cancer/Bowel-Screening/. Last accessed December 2014

5 Scottish Medicine Consortium. Cetuximab (Erbitux). Available at http://www.scottishmedicines.org.uk/SMC_Advice/Advice/543_09_cetuximab__Erbitux_/cetuximab__Erbitux_1.Last accessed December 2014

6 Cancer Research UK. Bowel cancer key facts. Available at http://www.cancerresearchuk.org/cancer- info/cancerstats/keyfacts/bowel-cancer/cancerstats-key-facts-on-bowel-cancer. Last accessed December 2014

7 Hagan S et al. Targeted therapies in colorectal cancer – an integrative view by PPPM. EPMA Journal 2013;4:3 http://www.epmajournal.com/content/4/1/3

Source: Merck Serono