HATFIELD, England, October 10, 2016 /PRNewswire/ --

Patients in England denied access to lenvatinib due to administrative delays  

The Scottish Medicines Consortium (SMC) approves the use of Lenvima^® (lenvatinib) for people with radioactive iodine refractory differentiated thyroid cancer (RAI-R DTC) in Scotland.^[1] Advanced thyroid cancer has a poor prognosis with a 10-year survival rate of around 15%^[2] and lenvatinib represents a significant step forward for patients in Scotland.

Lenvatinib is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine
(RAI-R DTC).^[3]

The availability of lenvatinib in Scotland contrasts with England, where the treatment may not be available to people with RAI-R DTC for a further two years. In July this year, NICE confirmed that guidance on the use of lenvatinib will not be published until at least 2018. Lenvatinib received a marketing authorisation from the European Commission more than a year ago, in May 2015.^[1]

NHS England appears to be blocking patient access to lenvatinib, despite the clear clinical need. Eisai is aware of scores of individual funding requests made by clinicians for the use of lenvatinib in eligible patients, and no patient has yet received the treatment.

Thyroid cancer incidence rates have increased in the UK over the past few decades,^[4] with 3,241 new cases diagnosed in 2013.^[4] Standard treatment for early and locally spread differentiated thyroid cancer is surgery to remove the thyroid gland, followed by radioactive iodine ablation (radioiodine) and endocrine therapy.^[5],[6] However approximately 5% of patients fail to respond to this treatment and develop RAI-R DTC.^[7] In 2013 there were approximately 160 people in the UK with RAI-R DTC.^[4],[7]

"The Beatson Oncology Centre participated in the phase 3 clinical trial with lenvatinib in patients with advanced thyroid cancers which were refractory to radio iodine. The SELECT study showed that treatment with lenvatinib can significantly delay the progression of advanced thyroid cancer. In addition lenvatinib showed high objective response rates indicating that the treatment is likely to be effective in a large number of patients with the condition. Both of these factors are of great importance to patients and their families. The announcement of the approval of the use of lenvatinib for patients with advanced thyroid cancer is really positive news and gives us a choice of drugs in this difficult to treat condition," comments Dr Nick Reed, Consultant Clinical Oncologist, Beatson Oncology Centre, Glasgow and investigator on the SELECT trial.

"There are a small number of people who live with thyroid cancer that has stopped responding to radioiodine. Until recently there have been very few effective treatment options available. I am sure that both patients, and the clinicians looking after them, will welcome the decision of the SMC to allow lenvatinib as a first line treatment option," comments Dr Leslie Samuel, Macmillan Consultant Oncologist at Aberdeen Royal Infirmary.

In the SELECT study, Lenvatinib demonstrates significantly prolonged progression-free survival (PFS) in RAI-R DTC versus placebo.^[8] Lenvatinib shows a median 18.3 months PFS versus 3.6 months for placebo (hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, p<0.001).^[8] In addition, the study underlines the rapid response of lenvatinib, with a median time to first objective response of two months and objective response rate versus placebo of 64.8% versus 1.5%; p<0.001.^[8] For lenvatinib, the most common treatment related adverse events of any grade were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.^[8] The New England Journal of Medicine published SELECT study, a randomised, double-blind, multicentre trial for people with progressive radioactive iodine refractory differentiated thyroid cancer (n=392).^[8]

In August, the European Commission issued a marketing authorisation for lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.^[9] Lenvatinib was granted an accelerated assessment by the European Medicines Agency in October 2015.

"The availability of lenvatinib is clearly a positive step forward for people in Scotland who live with this rare form of thyroid cancer. We are encouraged that the SMC has moved quickly to ensure people in Scotland will be able to access such a treatment that patients respond to rapidly with a proven progression-free survival benefit. However, Eisai remains extremely disappointed and desperately unhappy by the total lack of any flexibility shown by NHS England in providing earlier access to patients in England than is currently anticipated. In their approval, the SMC have ruled that lenvatinib is both clinically and cost effective. This proves unequivocally that the process in England is seriously flawed," comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

Lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.^[10],[11] Lenvatinib has been approved for the treatment of radioiodine refractory differentiated thyroid cancer in the United States, European Union, Russia, Switzerland, Australia, Canada, Israel, Singapore, Japan, South Korea and Brazil.

The development of lenvatinib underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and the unmet medical needs of patients and their families.

Notes to Editors 

Lenvima^® (lenvatinib)  

Eisai is currently conducting clinical studies of lenvatinib in several types of cancer including hepatocellular carcinoma (phase III), renal cell carcinoma (phase II), non-small cell lung cancer (phase II) and endometrial cancer (phase II).

About SELECT^[8]

SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) is a multicentre, randomised, double-blind, placebo-controlled phase III study of patients with radioiodine-refractory differentiated thyroid cancer, treated with once-daily, oral lenvatinib (24mg).^[8] The study enrolled 392 patients in over 100 sites in Europe, Americas, Asia, and Australia.^[8]

About Thyroid Cancer 

Thyroid cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.^[12] Thyroid cancer affects more than 52,000 people in Europe each year.^[13]

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References  

1. Scottish Medicines Consortium Decision.
2. Desphande H, Gettinger S, et al. Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer. Core Evidence, 2009;4:43-8
3. SPC Lenvima (lenvatinib) (updated June 2015). Available at: http://www.medicines.org.uk/emc/medicine/30412. Accessed September 2016
4. Cancer Research UK. Thyroid Cancer Incidence Statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/thyroid/incidence/uk-thyroid-cancer-incidence-statistics Accessed: September 2016
5. Antonelli A et al. Current Genomics 2001;12:626-31
6. Sacks W, Braunstein G. Clinically meaningful endpoints in the evolving treatment paradigm for radioactive iodine-refractory differentiated thyroid cancer. Expert Review of Endocrinology & Metabolism. Early online, 1-8 (2015).
7. Xing MM, Haugen B, et al. Progress in molecular-based management of differentiated thyroid cancer. The Lancet 2013; 381: 1058-698.
8. Schlumberger M, Tahara M, et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM, 2015; 372: 621-630. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 Accessed: October 2016
9. SPC Kisplyx (lenvatinib), (updated September 2016). Available at: https://www.medicines.org.uk/emc/medicine/32335. Accessed: October 2016
10. Matsui J, Yamamoto Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. International Journal of Cancer 2008;122:664-671
11. Okamoto K, Ikemori-Kawada M, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter 2014;6:89-94
12. National Cancer Institute at the National Institute of Health. Thyroid Cancer Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 Accessed: October 2016
13. EUCAN 2015. Thyroid Cancer. Available at: http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35 . Accessed: October 2016

SOURCE Eisai