CAMBRIDGE, England, March 7, 2017 /PRNewswire/ --
The National Institute for Health and Care Excellence (NICE) issued a Final Appraisal Determination (FAD) on 2 March recommending panitumumab as an option for patients with previously untreated, RAS wild-type metastatic colorectal cancer in adults in combination with the FOLFOX or FOLFIRI chemotherapy regimes. NICE evaluated the clinical and cost-effectiveness of panitumumab and cetuximab in the Multiple Technology Appraisal (MTA) and concluded that both are cost-effective use of NHS resources.[1]
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Professor Richard Wilson, Professor of Cancer Medicine at Queen's University Belfast said, "The overall 5-year survival rate for patients with metastatic colorectal cancer is around 10 percent, highlighting the need for targeted treatments like panitumumab to help patients. The assessment from NICE reinforces the importance of panitumumab with chemotherapy for patients in clinical practice, particularly for shrinking tumour tissue for surgical resection and slowing disease progression, which prolongs life and improves both symptoms and quality of life."
The FAD recommends panitumumab within its marketing authorisation* and on the basis of the discounts agreed in the patient access scheme with NICE. Panitumumab is the only fully-human monoclonal anti-epidermal growth factor receptor (EGFR) antibody authorised for the treatment of wild-type RAS metastatic colorectal cancer.
"Through Amgen's continued commitment and work with NICE, along with our partner's and stakeholder's determination, we are pleased that the treatment is now recommended, meaning that people will now be able to gain access to panitumumab on the NHS." said Tony Patrikios, Executive Medical Director at Amgen UK. He added, "Previously, people were only able to access panitumumab through the Cancer Drugs Fund, subject to satisfying the eligibility criteria for the treatment."
Colorectal cancer is the fourth most common cancer in the UK and accounts for 12 percent of all new cases of cancer. It is the third most common cancer found in both men and women.[2] Colorectal cancer is the second most common cause of cancer deaths in the UK. With nearly 16,000 deaths a year, there still is a clear need for treatment options for patients. Approximately 25 percent of people with colorectal cancer have metastatic disease when first diagnosed, and approximately 50 percent of people who have surgery for early stage disease will eventually develop metastases.[3]
The NICE FAD for panitumumab is published as a Multiple Technology Appraisal (MTA), which also includes cetuximab. Both treatments were recommended within their marketing authorisation, provided they meet the discounts agreed in their patient access schemes. The FAD is not NICE's Final Guidance for panitumumab - it is expected to become Final Guidance to the NHS in England and Wales in April 2017.
*For first-line treatment, panitumumab is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer in combination with FOLFOX or FOLFIRI.
Please refer to the Summary of Product Characteristics for full European prescribing information: https://www.medicines.org.uk/emc/medicine/20528
About Vectibix® (panitumumab) in Europe
Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) antibody licensed by the European Commission (EC) for the treatment of wild-type RAS metastatic colorectal cancer (mCRC).[4] The safety and efficacy of panitumumab have not been studied in patients with renal or hepatic impairment.[4] Panitumumab was first authorised by the EC in December 2007 as a monotherapy for the treatment of patients with EGFR-expressing mCRC with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.
In Europe, panitumumab is indicated for the treatment of adult patients with wild-type RAS mCRC:[4]
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit http://www.amgen.co.uk.
References:
1. NICE Final Appraisal Determination - cetuximab and panitumumab for previously untreated metastatic colorectal cancer. Available from https://www.nice.org.uk/guidance/indevelopment/gid-tag470 Last Accessed March 2017
2. Cancer Research UK: Bowel Cancer Incidence. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer#heading-Zero Last Accessed March 2017
3. Van Cutsem E, Cervantes A, Nordlinger B, et al., Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology: official journal of the European Society for Medical Oncology. 2014; 25 (supplement): iii1-iii9
4. Vectibix® (panitumumab) Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/20528 Last Accessed March 2017
Job number: UKIE-CC-954-0217-046139
Date of preparation: March 2017
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