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Final NICE guidance recommends GIOTRIF® (afatinib) for first-line treatment of EGFR mutation positive advanced lung cancer

Lung cancer patients in the UK now have access to a new targeted treatment Giotrif® (afatinib), the first oncology treatment to be developed by Boehringer Ingelheim. The National Institute for Health and Care Excellence (NICE) has issued its final Health Technology Appraisal recommending afatinib as a first-line treatment option “for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)”.1 Afatinib is only the second oncology drug to be approved by NICE in the past fourteen months2 and was the only EGFR TKI in lung cancer to go straight to Final Appraisal Determination (FAD) based on the strength of the clinical and cost-effectiveness evidence.1,3,4

NHS England has recommended that afatinib is reimbursed at day zero, rather than after the standard 90 day implementation period. This will allow lung cancer patients to have immediate access to afatinib should their clinician wish to prescribe it.

“I am delighted that this will end uncertainty and standardise access to afatinib for patients in England following last month’s acceptance in Scotland. It is now the responsibility of the NHS in England to provide funding. This will ensure that patients living with EGFR mutation positive advanced non-small cell lung cancer can benefit from first-line treatment with afatinib without delay,” commented Zinta Krumins, Managing Director Boehringer Ingelheim UK/Ireland.

In the UK about 43,500 people are diagnosed with lung cancer5 and there are around 35,000 deaths per year, which is more than breast cancer and prostate cancer combined (22,555).5

Lung cancer is still seen mainly as a smoker’s disease however, 10-15% of cases of lung cancer are not linked with smoking6 and lung cancer patients who have never smoked are more likely to have a mutation change in the EGFR.7

Afatinib is a new, once-daily, tablet which targets the entire ErbB family of receptors which are known to play a critical role in helping cancer cells grow.8-11

Data submitted to NICE included the key studies LUX-Lung 3 and LUX-Lung 6 conducted in EGFR mutation positive patients with advanced lung cancer. In the two phase III studies, patients receiving afatinib lived for longer without their tumour growing (known as progression free survival, PFS) compared to chemotherapy.12,13

LUX-Lung 3, the largest global phase III trial in patients with EGFR mutation positive advanced lung cancer, showed that patients taking afatinib as a first line treatment lived for an average of 11.1 months without their tumour growing (PFS) versus 6.9 months for those treated with pemetrexed/cisplatin (HR 0.58; p<0.001). Side-effects seen with afatinib were manageable through dose reductions and supportive care, with 8% of patients discontinuing due to afatinib related side effects, compared to 12% in the chemotherapy arm. The most common side effect was diarrhoea with 1.3% of patients discontinuing treatment due to this.12

In the companion trial in Asian patients – LUX-Lung 6, EGFR mutation positive patients with advanced lung cancer taking afatinib as a first line treatment, lived for an average of 11.0 months without their tumour growing (PFS), versus 5.6 months for those treated with gemcitabine/cisplatin (HR 0.28; p<0.0001).13

About Giotrif® (afatinib)

Afatinib is an ErbB family blocker which blocks EGFR (ErbB1) as well as the other relevant members of the ErbB family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality.14,15 Afatinib has today received its final Health Technology Appraisal from the NICE, who are recommending afatinib as an option for first-line patients with advanced NSCLC with a mutation (or change) in the EGFR. 8-11

Source

1 NICE recommendation of Giotrif® [Online] Available at: http://guidance.nice.org.uk/TA310/Guidance/pdf/English Last Accessed: April 2014

2NICE. Published technology appraisals. [Online] Available at: http://www.nice.org.uk/guidance/ta/published/index.jsp?p=off Last Accessed: April 2014

3 NICE. Press releases. [Online] Available at: http://www.nice.org.uk/newsroom/pressreleases/ErlotinibLungCancerACD.jsp Last Accessed: April 2014

4NICE. Press releases. [Online] Available at: http://www.nice.org.uk/newsroom/pressreleases/2010061gefitinib.jsp Last Accessed: April 2014

5Cancer Research UK. Cancer Incidence and Mortality in the UK. [Online] Available at: http://publications.cancerresearchuk.org/downloads/Product/CS_REPORT_TOP10INCMORT.pdf Last Accessed: April 2014

6Roy Castle Lung Cancer Foundation. Understanding Lung Cancer [Online] Available at: http://www.roycastle.org/lung-cancer/Understanding+Lung+Cancer Last Accessed: April 2014

7 Biochemistry Research International. Genetic and Biochemical Alterations in Non-Small Cell Lung Cancer [Online] Available at: http://www.hindawi.com/journals/bri/2012/940405/ Last Accessed: April 2014

8GIOTRIF® 20mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

9GIOTRIF® 30mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

10 GIOTRIF® 40mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

11 GIOTRIF® 50mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

12 Sequist LV, Yang JC, Yamamoto N et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013; 31(27):3327-3334

13 Wu YL, Zhou C, Hu CP et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014; 15(2):213-222

14 Solca F, Dahl G, Zoephel A et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012;343:342-50

15 Reid A, Vidal L, Shaw H et al. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer. 2007; 43:481-489

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