NICE approval for differentiated thyroid cancer drug

Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) issued its final appraisal decision (FAD) recommending reimbursement of Lenvima^® (lenvatinib) for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine (RAI-R DTC).¹

This decision is part of a Multiple Technology Assessment resulting in the recommendation of both lenvatinib and sorafenib.

Thyroid cancer is the fastest growing cancer diagnosis in the UK² and generally the prognosis is quite good, leading it to being mistakenly seen as a better cancer to have. However, the aggressive form of DTC, in which patients are refractory to radioactive iodine therapy, carries a poorer prognosis with 66% of patients dying within five years of diagnosis.³ There were approximately 3388 people diagnosed with thyroid cancer in the UK in 2014. It is also estimated that 5-15% of patients with differentiated thyroid cancer develop RAI-refractory DTC.⁴

The European Medicines Agency (EMA) approval and subsequent NICE recommendation was based on the pivotal Phase III SELECT study that showed lenvatinib was associated with significant improvements in progression-free survival (PFS) in patients with progressive RAI-R DTC.² Median PFS with lenvatinib was 18.3 months compared to 3.6 months on placebo (HR 0.21; 99% CI 0.14–0.31, p<0.001).⁵ In addition, the objective response rate was 64.8% versus 1.5% with placebo (p<0.001).⁵

In this study, the most common treatment-related adverse events for lenvatinib were hypertension, diarrhoea, fatigue or asthenia, decreased appetite, decreased weight and nausea.⁵

“This is fantastic news for the many patients in the UK who are diagnosed with advanced thyroid cancer. From the patient’s perspective, having treatment options is very important and with this recommendation NICE are providing exactly that,” commented Dr Jonathan Wadsley, Consultant Clinical Oncologist, Weston Park Hospital and Clinical Lead for Division 1 Yorkshire and Humber Clinical Research Network.

This positive NICE recommendation comes after the EMA approved lenvatinib for use almost three years ago in May 2015, and the Scottish Medicines Consortium (SMC) approved it for reimbursement in October 2016. This was followed by the All Wales Medicines Strategy Group’s approval in October 2017.⁶

“After almost three years of being licensed in the EU, I am really very pleased that NICE is finally recommending the use of lenvatinib so that patients with this form of thyroid cancer will at last have access to it in England. While patients in Scotland and Wales had access to lenvatinib much sooner – 2016 and 2017 respectively – it’s a real shame that due to a poor process that patients in England have had to wait much longer,” commented Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai. “Eisai’s dedication to ensuring rapid and sustained access to innovative treatments reinforces our human health care (hhc) mission to benefit patients and families affected by difficult-to-treat cancers.”

Lenvatinib is an oral, once-daily, selective tyrosine kinase inhibitor (TKI) which has a binding mode that appears to simultaneously inhibit the activities of numerous receptor proteins implicated in tumour growth and spread. Its blockade of fibroblast growth factor receptor 1 (FGFR 1), which has division, growth and regulatory cellular functions, and is overexpressed in some cancers, together with blockade of VEGF (vascular endothelial growth factor) receptors which play a role in pathological angiogenesis, represents a dual blockade of tumour growth.^7-9

Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai’s human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.

References

1. National Institute of Health and Care Excellence. Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine [ID1059] Available at: www.nice.org.uk/guidance/indevelopment/gid-ta10101/documents. Last accessed: February 2018.
2. Smittenaar CR et al. (2016) Cancer incidence and mortality projections in the UK until 2035. British Journal of Cancer. 115:1147–1155
3. Nixon IJ, et al. (2012) The impact of distant metastases at presentation on prognosis in patients with differentiated carcinoma of the thyroid gland. Thyroid. 22:884–9.
4. Worden F. (2014) Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Therapeutic Advances in Medical Oncology. 6(6):267–79
5. Schlumberger M et al. (2015) Lenvatinib versus Placebo in Radioiodine-Refractory Thyroid Cancer. NEJM. 372:671-30
6. All Wales Medicines Strategy Group (2017) Final Appraisal Recommendation. Advice No: 1817 Lenvatinib (Lenvima^®) 4 mg and 10 mg hard capsules. Available at: www.awmsg.org/awmsgonline/app/appraisalinfo/976. Last accessed February 2018.
7. eMC. Lenvatinib Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/medicine/30412. Last accessed February 2018
8. Matsui J, et al. (2008) 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. Int J Cancer. 122:664-671
9. Stjepanovic N, et al. (2014) Multikinase inhibitors in the treatment of thyroid cancer: specific role of lenvatinib. Biologics. 8:129-39.