Hatfield, UK, 10 October 2016–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.[i] Advanced thyroid cancer has a poor prognosis with a 10-year survival rate of around 15%[ii] 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
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 In July this year, NICE confirmed that guidance on the use of lenvatinib will not be published until at least 2018.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,[iv] 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.[v],[vi] However approximately 5% of patients fail to respond to this treatment and develop RAI-R DTC.[vii] In 2013 there were approximately 160 people in the UK with RAI-R DTC.4,7
“There are a small number of people who live with thyroid cancer that has stopped responding to radioiodine. Until recently there have 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.[viii] 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).7 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<0.001.7 For lenvatinib, the most common treatment related adverse events of any grade were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.7 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).7
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.[ix] 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. [x],[xi] 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.Editor's Details
Last updated on: 11/10/2016
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