Rare Cancer Drug Which Significantly Delays Progression of Advanced Thyroid Cancer is Left Off Relaunched Cancer Drugs Fund

HATFIELD, England, August 2, 2016 /PRNewswire/ --

People with radioiodine refractory differentiated thyroid cancer (RAI-R DTC) are overlooked as Lenvima^® (lenvatinib) is not scheduled for evaluation by NICE or the new Cancer Drugs Fund   

People with an advanced form of thyroid cancer have to wait up to two to three years before being able to access Lenvima (lenvatinib) in England, due to failures in the new Cancer Drugs Fund (CDF) procedure launched on 29 July. Lenvatinib can significantly slow the progression of disease; in its pivotal trial, the treatment provided a significant median progression free survival benefit of 18.3 months versus 3.6 months for placebo (p<0.0001) in radioiodine refractory differentiated thyroid cancer.^[1] Further, nearly two-thirds of patients responded (ORR measure) to the treatment with a significant objective response rate (ORR) of 64.8% versus placebo 1.5% (p<0.0001). The treatment also demonstrated a rapid response, with a median time to first objective response of only two months. Adverse events were seen in nearly all lenvatinib patients (97.3% on lenvatinib versus 59.5% on placebo) and the most common were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight and nausea.^[1]

Lenvatinib is indicated for the treatment of adults with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI-R)^[2] and was granted an accelerated assessment and approved by the European Commission in May 2015. It is available in many countries in Europe already, including Germany where it has been available from May 2015.

Lenvatinib is not listed on the relaunched CDF and NICE has indicated it will not be able to issue final guidance on the treatment until around June 2018. Lenvatinib has been in limbo ever since 2015, when it was refused entry to the CDF as it was closed to new medicines and was not scheduled for assessment by NICE due to its low budget impact. To compound this situation, Eisai is aware of at least twenty individual funding requests made by clinicians in England for the use of lenvatinib in eligible patients, and no patient has yet received the treatment.

Eisai calls for a flexible solution in the form of urgent transitional arrangements that would ensure patients can access lenvatinib through the CDF. Eisai has met with NHS England and NICE but despite extensive dialogue, to date no agreement has been made.

"As a clinician I am now in the difficult position of having to explain to my patients why I cannot prescribe a drug that is available in other European countries. This is obviously very disappointing given the significant progression free survival benefit demonstrated by lenvatinib for patients with radioiodine refractory DTC and my colleagues and I will not be able to do so in the immediate foreseeable future," comments Dr Nick Reed, Consultant Clinical Oncologist, Beatson Oncology Centre, Glasgow, UK.

"On behalf of patients with advanced thyroid cancer, we have no option but to fight this inequitable situation. For once this is not about cost as we have not been asked to be evaluated for clinical or cost effectiveness but we would welcome the opportunity to do so but also the new CDF is underwritten by the pharmaceutical industry where we take 100% of the financial risk associated with the Fund. This situation would indicate that England is turning the clock back and fast becoming the sick child of Europe in terms of access to innovative cancer drugs. Eisai will therefore fight aggressively for the rights of patients, which may include taking legal action.

"Lenvatinib was developed in the UK and is now manufactured in Hertfordshire in our state of the art facility. With no access to lenvatinib for people with advanced thyroid cancer in the UK for possibly three years, we may be forced to reconsider our future investments here, The NHS is one of the best healthcare systems in the world and so there simply must be a solution for patients," comments Gary Hendler, Chairman and CEO Eisai EMEA.

Notes to Editors    

About Thyroid Cancer   

2,800 people are diagnosed with thyroid cancer each year in England,^[3] and approximately 250 will not respond to radioiodine treatment and develop RAI-R DTC.^[2],[4]People with RAI-R DTC and distant metastases have a median survival of 2.5-3.5 years^[3] and few treatment options are currently available on the NHS in England

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.^[5] The incidence of thyroid cancer has increased significantly in the last decade by 69% and 65% in men and women, respectively.^[6] The most common types of thyroid cancer, papillary and follicular (including Hürthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases.^[6] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).^[7]

About SELECT^[1]
The decision by the EC was based on the results of a multicenter, randomized, double-blind, placebo-controlled Phase III study (the SELECT study) on progressive RAI refractory differentiated thyroid cancer.^[1] The study's primary endpoint was progression-free survival (PFS).

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. Schlumberger 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: August 2016

2. Summary of Product Characteristics Lenvima. 2015.

3. 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: August 2016

4. Durante 2006. J. Clin. Endo & Met. 91(8):2892-2899

5. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 . Accessed: August 2016

6. Cabanillas ME., Dadu R. Optimizing therapy for radioactive iodine-refractory differentiated thyroid cancer: Current state of the art and future directions. Minerva Endocrinol 2012 Dec; 37(4): 335-356.

7. Thyroid Cancer Basics. 2011.  Available at: http://www.thyca.org . Accessed: August 2016