Eisai Slams the New Cancer Drug Fund that Further Delays Patient Access to New Cancer Drug

HATFIELD, England, February 25, 2016 /PRNewswire/ --

Eisai has criticised strongly NHS England (NHSE) for further delaying access to a number of new cancer treatments. This failure is a result of the implementation by NHSE of a new Cancer Drugs Fund (CDF), following a consultation NHSE confirmed at their Board meeting today. Those new licensed drugs that have been denied access since May 2015, will have to wait until at least July 2016 before they can be considered for the fund, though details around this process are vague.

Lenvima^® (lenvatinib) is one such drug that has been stuck in limbo as a result of the consultation. Lenvatinib is used to treat an advanced form of thyroid cancer and may delay the progression of the cancer to a median of 18.3 months, compared to 3.6 months with placebo. Eisai today confirms that patients in England may have to wait for an unspecified period in order to access lenvatinib.

"This is devastating news for patients with advanced thyroid cancer. These patients may belong to a small group, only 200 patients per year, but their need is great. Lenvatinib can make a real difference to the lives of patients due to its significant progression free survival benefit and so this news is particularly hard to understand," comments Dr Jonathan Wadsley, Consultant Clinical Oncologist, University of Sheffield.

 "This is hugely disappointing news for people living with thyroid cancer that has proved resistant to usual therapies. There are very few treatment options left for those patients whose thyroid cancer is not responsive to radio-iodine. The fact that an approved treatment exists which could delay progress of their cancer but they are not able to access it is particularly heartbreaking," comments Kate Farnell MBE, Founder of the Butterfly Thyroid Cancer Trust.

"The decision to implement the new CDF pretty much as it was proposed in the consultation will put cancer treatment back to where England was prior to the creation of the Fund which is a tragedy for patients. Time is not a luxury that these patients have. I implore NHS England to rethink the decision around access to drugs that have been licensed since May 2015 to ensure important treatments like lenvatinib are made available to people as soon as possible. This is a drug that is manufactured in Hertfordshire, exported across the world, and yet people in England are denied access to it. This is an utterly disgraceful situation", commented Gary Hendler, CEO Eisai EMEA and President, Global Oncology Business Unit.

Lenvatinib is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).^[i] Lenvatinib was granted orphan drug designation for locally advanced follicular and papillary thyroid cancer. The treatment was given Marketing Authorisation approval from the European Commission in May 2015, and has been denied access to the CDF process ever since.

Lenvatinib demonstrates significantly prolonged progression-free survival (PFS) in RAI refractory DTC versus placebo. Lenvatinib shows a median 18.3 months progression free survival PFS versus 3.6 months for placebo (hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, p<0.0001). For lenvatinib, the most common treatment related adverse events were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.

Notes to Editors    

About SELECT^[i]  

The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR- radioiodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.

Participants were stratified by age (≤65, >65 years), region and ≤1 prior VEGFR-targeted therapies and randomised 2:1 to either lenvatinib or placebo therapy (24mg/d, 28-d cycle). The primary endpoint was PFS assessed by independent radiologic review. The secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. Data presented at ASCO 2014 and subsequently published in the New England Journal of Medicine showed that rates of complete response were 1.5% (4 patients) for the lenvatinib group and zero in the placebo group. The results for partial response were 63.2% (165 patients) in the lenvatinib group and 1.5% (2 patients) in the placebo arm. The median exposure duration was 13.8 months for lenvatinib and 3.9 months for placebo and the median time to response for lenvatinib was 2.0 months. The difference in OS between the groups was not significant. The confidence interval upper limit of median OS has not yet been reached.

The six most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension (67.8%), diarrhea (59.4%), fatigue (59.0%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41.0%). TRAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) included hypertension (41.8%), proteinuria (10.0%), weight loss (9.6%), diarrhoea (8.0%), and decreased appetite (5.4%).

About Thyroid Cancer   

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.^[ii] Most people are in their 40s or 50s at time of diagnosis.^[iii]

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases.^[iv] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).^[v]

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    

i. 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: November 2015

ii. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 . Accessed: June 2015

iii. Brito J et al. BMJ 2013; 347

iv. 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.

v. Thyroid Cancer Basics. 2011. Available at: http://www.thyca.org. Accessed: June 2015