Eisai: U.K. NICE Recommends Anticancer Agent Lenvima as Treatment for Thyroid Cancer
2018年2月16日 - 8:34AM
JCN Newswire (英)
Eisai Co., Ltd. announced today that its in-house developed
anticancer agent Lenvima (lenvatinib mesylate, lenvatinib) has been
recommended by the U.K. National Institute for Health and Clinical
Excellence (NICE) as a treatment for progressive, locally advanced
or metastatic differentiated thyroid cancer (papillary, follicular
or Hurthle cell) in adults whose disease does not respond to
radioactive iodine, in NICE's Final Appraisal Determination
(FAD).(1)
Following the issue of the FAD by NICE, lenvatinib will be eligible
for reimbursement for this indication via the National Health
Service in England (NHS England).
The Appraisal Committee considered that lenvatinib demonstrated a
statistically significant improvement in progression free survival
and offers an extension in overall survival compared to placebo,
respectively.
The committee concluded that lenvatinib is one of the few treatment
options for progressive, locally advanced or metastatic
differentiated thyroid cancer after surgery and radioactive
iodine.
Lenvatinib was approved in Europe in May 2015 as a treatment for
adults with progressive, locally advanced or metastatic
differentiated thyroid cancer (papillary, follicular or Hurthle
cell), refractory to radioactive iodine. The agent was launched in
the U.K. in June 2015. Furthermore, lenvatinib was approved in
September 2016 for an expanded indication 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, and lenvatinib is marketed under
the product name Kisplyx for this indication.
Lenvatinib plus everolimus was recommended by NICE as an option for
treating advanced renal cell carcinoma in adults who have had one
previous VEGF-targeted therapy in December 2017.
Eisai regards oncology as a key therapeutic area and is aiming to
discover revolutionary new medicines with the potential to cure
cancer. Eisai remains committed to providing further clinical
evidence and expanding patient access for lenvatinib, and by
maximizing the value of the drug, seeks to contribute further to
addressing the diverse needs of, and increasing the benefits
provided to, patients with cancer, their families, and healthcare
providers.
About lenvatinib mesylate (product name: Lenvima / Kisplyx,
lenvatinib)
Discovered and developed in-house, lenvatinib is an orally
administered multiple receptor tyrosine kinase (RTK) inhibitor with
a novel binding mode that selectively inhibits the kinase
activities of vascular endothelial growth factor (VEGF) receptors
(VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF)
receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other
proangiogenic and oncogenic pathway-related RTKs (including the
platelet-derived growth factor (PDGF) receptor PDGFRalpha; KIT; and
RET) involved in tumor proliferation.
Currently, Eisai has obtained approval for lenvatinib as a
treatment for refractory thyroid cancer in over 50 countries,
including the United States, Japan, in Europe and Asia, under the
brand name Lenvima. Additionally, Eisai has obtained approval for
lenvatinib in combination with everolimus as a treatment for renal
cell carcinoma (second-line) in over 40 countries, including the
United States and in Europe. In Europe, the agent was launched
under the brand name Kisplyx for renal cell carcinoma.
Furthermore, in a Phase III clinical study (REFLECT Study / Study
304) comparing safety and efficacy of the agent versus sorafenib
for the treatment of hepatocellular carcinoma, lenvatinib achieved
its primary endpoint of overall survival, meeting the statistical
criteria for non-inferiority to sorafenib. Eisai has submitted
applications for an indication covering hepatocellular carcinoma in
Japan (June 2017), the United States and Europe (July 2017), China
(October 2017), Taiwan (December 2017) and other countries.
A Phase III study of lenvatinib in separate combinations with
everolimus and pembrolizumab in renal cell carcinoma (first-line)
is underway. A Phase Ib/II study to investigate lenvatinib in
combination with pembrolizumab in select solid tumors (endometrial
cancer, renal cell carcinoma, non-small cell lung cancer,
urothelial cancer, head and neck cancer, and melanoma) and a Phase
Ib study in HCC are also underway. Additionally, a Phase Ib study
to investigate lenvatinib in combination with nivolumab in HCC has
been initiated in Japan.
About NICE's New Approach to the Appraisal and Funding of Cancer
Drugs
The former Cancer Drugs Fund (CDF) was established in 2009 as a
means to improve patients' access to new cancer drugs including
those which were "Not Recommended" by NICE. These drugs would be
evaluated and listed in the CDF with their costs reimbursed through
the fund. However, due to a severe increase in financial burden, a
new scheme for NICE appraisal and funding of cancer drugs,
including a new CDF, came into operation on July 29, 2016.
All novel cancer drugs that had been newly approved would undergo
NICE appraisal while cancer drugs that were listed in the former
CDF would be eligible for reappraisal by NICE under the new scheme
depending on the judgment of each company. The NICE appraisal
process consists initially of an Appraisal Consultation Document,
the issue of a Final Appraisal Determination, and ultimately the
setting of Final Guidance. While cancer drugs that are
"Recommended" are eligible for reimbursement through the NHS
England, drugs that are "Not Recommended" require an Individual
Funding Request (IFR) to be deliberated on a case-by-case basis,
and therefore their use is greatly limited. Cancer drugs that could
possibly be recommended but are judged to lack sufficient evidence
can be given a "Limited Recommendation under the CDF", with
provisional access secured under the CDF for a maximum of two
years. After receiving this designation, NICE conducts a
reappraisal based on the new evidence, and ultimately determines
whether to either "Recommend" or "Not Recommend" the drug.
(1) "Alternative treatments for people with thyroid cancer to be
offered routinely on the NHS, says NICE"
https://www.nice.org.uk/news, accessed: February 15, 2018.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
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