news – page 17 – eisai china lnc.-威尼斯人888

on october 19, 2019, the “2019 ads beijing” sponsored by eisai china inc. was held in beijing, which is another platform for doctors’ information exchanges. featuring the theme of “let’s build hope together”, the main forum and three sub-forums focused on the latest cutting-edge academic research and clinical practice and development in china and in the world. 37 well-known experts and scholars from china, japan, singapore, spain and other countries, more than 300 on-site guests and nearly 1,000 on-line guests jointly discussed and conducted dialogues and interactions, producing collision of ideas and academic resonance between china and foreign countries.

at the beginning of the summit, mr. zhang jianzhong, vp and head of pharmaceutical business division of eisai china inc., delivered a speech. firstly, mr. zhang gave a warm welcome to all the experts and guests and sincerely thanked them for their strong support to the 2019 ads beijing summit. eisai china inc. will devote itself to building an academic exchange platform for cognitive disorders and continue to increase research and development of new drugs in this field. at the same time, adhering to its business philosophy of hhc (human health care), it will work hand in hand with all walks of life to make contributions in the cognition, prevention and control of diseases, patient care and other aspects.

zhang jianzhong delivered a speech

at this summit, professor jianping jia and professor luning wang were invited to act as chairmen of the summit. both of professor jia and professor wang expressed their thanks to eisai china inc. for setting up such an academic exchange platform to allow experts from many countries and guests to share academic and clinical practice and to jointly explore new modes of control and prevention of diseases in the field of cognitive impairment, and wished the summit a complete success.

a group photo of some experts

in the main forum, experts held academic discussions on issues such as the development of cognitive science, researches on the post-stroke cognitive impairment, researches on self-management of patients with alzheimer’s disease, the comparison of csf and blood biomarkers for alzheimer disease, researches on dlb and pdd drugs, advances and clinical treatment experiences of vad. they also held large-scale discussions on issues such as sleep and cognitive impairment, non-invasive biomarkers, and new target drugs for treatment of alzheimer’s disease, colliding their ideas and benefiting the participants.

photo of main forum

in the “practice” sub-venue, the themes were “measurement”, “observation”, “investigation”, “differentiation “, identification”, “treatment” and “practice”. speeches and case discussions and “on-the-spot consultation” mode discussions were conducted on the clinical applications of neurocognitive assessment, ad picture description, new progress in gene diagnosis of chinese population, truth and falsehood of senile depression “pseudodementia”, sharing of dlb or ad difficult cases, ad whole-process management and rational drug use. in the “field hotspots” sub-venue, from theory to practice, the participants interpreted in detail the “china guidelines for cognitive impairment related to cerebral small vessels (2019)”, “china expert consensus on post-stroke cognitive impairment rehabilitation” and “outpatient management standard for patients with post-stroke cognitive impairment”, and shared their experience and practical theories. in the “care for patients with alzheimer’s disease in all aspects” sub-venue, the participating experts shared and discussed the contents in three aspects: exploring a new management model for alzheimer’s disease, scientific care, and social support. the topics covered the medical care models based on family needs in shanghai, management system for patients with alzheimer’s disease, community two-way referral model, clinical characteristics and care needs of patients with alzheimer’s disease, setting of care plans and case analysis for the mentally retarded elderly, and consideration of long-term care for the elderly by the commercial insurance industry. in the exchanges and collision of opinions, the latest academic frontier progress and clinical practice experience were shared.

based on more than 35 years of drug research and development experience in the fields of alzheimer’s disease and dementia, eisai strives to realize the prevention and treatment of dementia through multidimensional and comprehensive methods. every year, many academic exchange activities sponsored by eisai china inc., such as empowering neurology’s future (enf), peripheral neuropathy summit (pns) and ads beijing summit, have become brands that are recognized and highly praised by doctors. eisai china inc. will always adhere to the philosophy of “hhc (human health care)” that “we give first thought to patients and their families, and to increasing the benefits health care provides. ” while providing disease solutions, it also provides long-term communication and learning platforms for medical professionals, and builds bridges for the exchanges of latest medical information at home and abroad.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today thateisai received a new drug approval for its in-house discovered and developed antiepileptic drug (aed) fycompa® (perampanel) from the china national medical products administration (nmpa) for use in an adjunctive treatment of partial onset seizures (with or without secondarily generalized seizures)in epilepsy patients 12 years of age and older. fycompa was designated for priority review by the nmpa due to itssignificant clinical benefits compared to existing treatments, and was approved in about 12 months since the submission in september 2018.

in china, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60% of whom being affected by partial-onset seizures. about 40% patients with partial-onset seizures require adjunctive treatment.¹as approximately30% of patients with epilepsy are unable to control their seizures with currently available aeds, ²this is a disease with significant unmet medical needs.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. administered orally once-daily, it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes.

fycompa has been approved in over 60 countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. in addition, fycompa has been approved in over 55 countries as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

eisai considers neurology including epilepsy, a therapeutic area of focus. with this approval of fycompa in china, eisai pursues our mission to provide “seizure freedom” to a greater number of patients with epilepsy across the world living. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

on october 13, 2019, eisai china inc. responded positively to the “2nd large-scale alzheimer-disease-month memory walk campaign” sponsored by alzheimer’s disease chinese, gave strong support and actively provided volunteer services.

wang li, representative of eisai china, delivered a speech

featuring the theme of “let’s talk about dementia: end the stigma”, this activity aimed to call on patients and their families to calmly face alzheimer’s disease, and to advocate the correct understanding and treatment of the disease and patients. by encouraging different social groups to take part in this activity, more social groups will understand and know about alzheimer’s disease, and the whole society will be called upon to change and abandon the negative and pessimistic views on alzheimer’s disease, and actively treat and pay attention to the disease and patients based on “people-orientation”. in the process of walking, through participating in relevant activities, we popularize knowledge of alzheimer’s disease to the public, spread the diagnosis and treatment methods of alzheimer’s disease and advocate the correct concept of medical treatment, enhance the public’s correct understanding of the disease and concern for alzheimer’s patients, promote the whole society’s understanding and support for the elderly with alzheimer’s disease and their families, say no to discrimination, create a friendly living environment, and encourage patients and their families to hold such an attitude: “let’s talk about dementia: end the stigma”.

a group photo of eisai china volunteers with the sponsor and experts
this activity was mainly divided into two parts, namely, the voice of various social groups, and healthy walking. first of all, the leaders from all walks of life, representatives of different social groups, and patients’ families spoke to express their concern and their heartfelt wishes for the disease, so that all walks of life could hear the understanding and concern about the disease from different groups, that the public can pay attention to the disease, correctly understand it and say no to discrimination. on the following walking route, five sites with the themes of “understand alzheimer’s disease”, “prevent alzheimer’s disease”, “treat alzheimer’s disease”, “care for alzheimer’s disease” and “pay attention to alzheimer’s disease” were set up. at each site there were 1-2 memory health booths from different units to popularize knowledge about alzheimer’s disease, offer activity experience and medical care and answer questions for residents on the scene.

we are willing to call on all sectors of society to participate, to help people understand the disease in a relaxing and healthy atmosphere, to pay attention to the disease and patients, to promote the development of the field, to build a good medical environment and to establish a sound disease support platform. we are committed to improving the social care and attention for patients with alzheimer’s disease, and cultivating and improving the professional skills of caregivers for the elderly with alzheimer’s disease.

eisai china inc. will always adhere to its business philosophy of hhc (human health care), that we give first thought to patients and their families, and to increasing the benefits health care provides.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and nichi-iko pharmaceutical (headquarters: toyama, president and ceo: yuichi tamura, “nichi-iko”) announced today that they have entered into a comprehensive collaboration agreement (hereinafter, “agreement”) for the generic pharmaceutical business in china.

the chinese pharmaceutical market is the second largest market in the world after the united states, and the generic drugs account for more than 70% of its market in terms of value. also, due to the rapid aging and the government’s policies to promote the generic drug market, the continuous growth of generic drugs is predicted. furthermore, in order to improve the quality of generic drugs, the chinese government is establishing the stable supply system of high quality generic drugs equivalent to the original drugs, such as it introduces the generic quality consistency evaluation system and provides priority response to the government’s centralized procurement system for the generic drugs which have passed its evaluation test.

under this agreement, eisai and nichi-iko aim to enhance their pharmaceutical businesses in china by introducing the high quality generic drugs which nichi-iko maintains the marketing approval in japan. eisai and nichi-iko specifically select the appropriate products for the chinese market needs, and eisai’s subsidiary in china sells the products after nichi-iko obtains the approval for import and sales in china. eisai and nichi-iko will select the first two products in this fiscal year, and subsequently prepare to launch one to two products every year for the continuous launch from fy2024.

due to this agreement, eisai will address a broader range of medical needs in china by further strengthening its chinese generic business since entering in 2015. nichi-iko aims to enter the chinese market leveraging the eisai’s business foundation in china, as part of the strategic imperatives, “business expansion” and “global operation” in the 8th medium-term management plan “nexus∞“.

in march 2018, eisai and nichi-iko has entered into a strategic alliance agreement for the generic pharmaceutical business in japan. by developing the partnership between eisai and nichi-iko in china, eisai and nichi-iko will aim to expand the contribution to patients in china as well as attempt to expand and grow their businesses in china.

the impact of the agreement has no impact on the financial results for fiscal 2019 for either company.

media inquiries

eisai co., ltd.
public relations department
tel: 81-(0)3-3817-5120
fax: 81-(0)3-3811-3077

nichi-iko pharmaceutical co., ltd.
president’s office
tel: 81-(0)76-442-7026
fax: 81-(0)76-415-8710

1. 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 approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology.

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

about nichi-iko pharmaceutical co., ltd.

since the establishment of nichi-iko group in 1965, nichi-iko has steadily developed its business to contribute to people’s health and quality of life by manufacturing high-quality, cost-effective pharmaceuticals. we shall excel as the outstanding generic pharmaceutical company, making every effort to continue to serve and deliver our products needed by our patients and their families, pharmacists, doctors, distributors and other pharma companies around the world. in working to fulfil this mission, we seek to earn the trust and respect of all our stakeholders and to be the first choice for our customers.

more patient-friendly, more patient-choice, more high-quality. that is what we mean by premium quality. and premium quality underpins our commitment to evolve into a global comprehensive generic pharmaceutical company.

for more information about nichi-iko pharmaceutical co., ltd., please visit

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and fronteo, inc. (headquarters: tokyo, ceo: masahiro morimoto, “fronteo”) announced today that they have launched the tumbling and falling prediction system coroban^® to medical institutions in japan on september 26, 2019. the coroban predicts inpatients’ tumbling and falling risks in advance and displays alerts.

through the launch of antiosteoporotic agent and insomnia treatment, a pharmaceutical company eisai has recognized that the preventive measures for tumbling and falling at medical institutions are important. on the other hand, fronteo healthcare, inc., a wholly owned subsidiary of fronteo, is a data analysis corporation focused on healthcare. it has originally developed an artificial intelligence (ai) system called concept encoder^®based on natural language processing technique.

eisai and fronteo have started the joint development for the coroban since january 2018. the coroban was introduced to several medical institutions in japan on a trial basis by leveraging eisai’s network with medical institutions, and advancing the improvements of coroban based on needs in the clinical settings has led to the launch of the coroban this time.

according to a survey by the ministry of health, labour and welfare, the number of inpatients aged 65 and over tends to increase to about 960,000 in 2017, therefore, the importance of cares for tumbling and falling in medical institutions is increasing. the coroban learns the nursing records of past inpatients at each medical institution, scores the tumbling and falling risks of individual inpatient from the daily nursing records based on these past records, and displays the information of inpatients with high risks. it is expected to reduce the burden of medical professionals and to make the risk assessment uniform and objective by reflecting the information in individual care and nursing plans for each patient’s tumbling and falling with the coroban.

through the launch of the coroban which supports to establish systems at nursing ward to reduce the tumbling and falling risks of inpatients, eisai and fronteo aim to contribute to the realization of well-being of patients and their families.

media inquiries
          eisai co., ltd.                                                fronteo, inc.
public relations department                     pr
tel: 81-(0)3-3817-5120                                tel: 81-(0)3-5463-6380

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and tokio marine & nichido fire insurance co., ltd. (head office: tokyo, president: shinichi hirose, “tokio marine nichido”) announced today that the companies have entered into a business alliance agreement for co-existence and prevention of dementia.

under this agreement, the following initiatives are scheduled: (1) “disease awareness initiatives” to dispel the misunderstandings and assumptions and to attempt for a widespread correct understanding of dementia, (2) “environment development” to implement the self-assessment of cognitive function on a daily basis, and (3) “measures to familiarize insurance product” to support people with dementia so they can continue to live their own lives. eisai and tokio marine nichido will work towards co-existence and prevention of dementia by mutually utilizing eisai’s abundant experience and knowledge of medicine creation and disease awareness activities in the field of dementia as well as tokio marine nichido’s expertise and networks cultivated in its insurance products and related services.

as part of dementia disease awareness activities, eisai and tokio marine nichido today began distribution of the booklet “wakaru to kawaru ninchisho – what is dementia?” that was co-produced based on eisai’s dementia experience and expertise.

^*please visit to browse or download the booklet “wakaru to kawaru, ninchisho – what is dementia?”. (japanese only)

this booklet simply summarizes the symptoms and types of dementia and progression of alzheimer’s disease. in addition, it includes interviews with specialists and medical staff about the images of dementia and the daily life of patients and their families living with dementia.

“misunderstandings and assumptions, such as people with dementia can’t understand anything or they are not themselves once they develop dementia, create the impression that dementia is terrible and misery. i hope this booklet will help educate people about the the reality of dementia by prodiving accurate information and dispelling misperceptions,” said dr. manabu ikeda, professor, department of psychiatry, osaka university medical school, who supervised this booklet.

the booklet for dementia disease awareness will be serialized and issued continuously.

with the rapid aging of the population, it is predicted that one out of five elderly people over the age of 65 will have dementia in japan. the “outline for promoting the dementia plan” was compiled by the government in june this year. the dementia barrier-free efforts are aimed at co-existence so that those with dementia can continue living the way they want in the communities they are used to living. the initiatives for prevention based on the co-existence foundation are expected to make significant progress.

eisai and tokio marine nichido will collaborate on initiatives for co-existence and prevention of dementia, including dementia disease awareness initiatives. the copmanies aim to contribute to the realization of the well-being of people with dementia and their families by considering collaboration with other companies and organizations that agree with the purpose of eisai and tokio marine nichido.

media inquiries
eisai co., ltd.                              tokio marine & nichido fire insurance co., ltd.
public relations department       public relations department
public relations group
tel: 81-(0)3-3817-5120   tel: 81-(0)3-5223-3212

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that a series of abstracts will be presented during the european society for medical oncology (esmo) 2019 congress taking place in barcelona, spain, from september 27 to october 1, 2019. the abstracts highlight updates regarding eisai’s in-house discovered lenvima^® (lenvatinib mesylate, the orally available kinase inhibitor, “lenvatinib”), and halaven^® (eribulin mesylate, “eribulin”, halichondrin class microtubule dynamics inhibitor).

at the esmo 2019 congress, there will be an oral presentation of results from the final analysis of the endometrial carcinoma cohort of study 111/keynote-146, a phase ib/ii study evaluating the combination treatment of lenvatinib and merck & co., inc., kenilworth, nj., u.s.a.’s anti-pd-1 therapy keytruda^® (pembrolizumab) in select solid tumors (abstract no.: 994o). the combination treatment was the first to be approved in the united states, australia and canada under the u.s. food and drug administration’s project orbis in september 2019.

a total of 11 poster presentations are scheduled, including one on the updated results of the lenvatinib plus pembrolizumab combination treatment in unresectable hepatocellular carcinoma in study 116/keynote-524, a phase 1b study (abstract no.: 747p), and the interim analysis evaluating the combination after disease progression after pd-1/pd-l1 immune checkpoint blockade in renal cell carcinoma (rcc) from 111/keynote-146 rcc cohort (abstract no.: 1187pd). in addition, the latest data from a phase i study for an eribulin liposomal formulation in solid tumors (abstract no.: 348p) will be presented.

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headqurters: tokyo, ceo: haruo naito, “eisai”) and meiji seika pharma co., ltd. (headqurters: tokyo, ceo: daikichiro kobayashi, “meiji”) today announced the manufacturing and marketing approval in japan for the indication of improvement of wearing-off phenomenon in patients with parkinson’s disease under treatment with a drug containing levodopa for equfina^®tablets (safinamide mesilate, “safinamide”), which was developed for use in the treatment of patients with parkinson’s disease was obtained. in japan, meiji holds the manufacturing and marketing approval for safinamide, and eisai exclusively sells the safinamide.

parkinson’s disease is a neurodegenerative disease which causes motor impairment, with symptoms including tremors in the limbs, muscular rigidity and shuffling gait. it is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. there are approximately 200,000 patients suffering from parkinson’s disease in japan¹, and the number of patients is increasing due to the aging of the population.^{1, 2} drugs containing levodopa are widely used to treat parkinson’s disease by replenishing the brain’s supply of dopamine. however, as the disease progresses, levodopa’s duration of effect (“on” time) decreases, and there are cases where patients may experience wearing-off phenomena, a return of parkinson’s disease symptoms before the next dose. safinamide through its main mechanism of action as a selective monoamine oxidase b (mao-b) inhibitor, increases the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain.

this manufacturing and marketing approval is based on a double-blind, placebo-controlled phase ii/iii study (study me2125-3) to evaluate the efficacy and safety of safinamide as add-on therapy and an open label phase iii study (study me2125-4) to evaluate the safety and efficacy of long-term administration of safinamide in japanese patients with parkinson’s disease with wearing-off phenomena who are currently receiving levodopa, as well as global clinical trials.

in study me2125-3, the change in mean daily “on” time from baseline to 24 weeks of the treatment phase, which is the primary endpoint, of treatment with safinamide 50 mg and 100 mg were statistically significant compared to placebo-controlled treatment. the most common adverse drug reactions (adrs) (incidence 3% and higher) observed with patients with safinamide 50 mg and 100 mg were dyskinesia and visual hallucination. also in study me2125-4, with regard to the change in mean daily “on” time from baseline to 52 weeks of the treatment phase, the “on” time with long-term administration of safinamide was extended, and showed the continued effectiveness. the most common adrs (incidence 3% and higher) observed with patients were dyskinesia, falls, and constipation.

by providing equifina tablets as a new option for parkinson’s disease treatment, eisai and meiji will make further contributions to address the diverse needs of, and increase the benefits provided to, parkinson’s disease patients and their families.

media inquiries

eisai co., ltd.                              meiji seika pharma co., ltd.
public relations department                           public relations
tel: 81-(0)3-3817-5120                       tel: 81-(0)3-3273-5614

¹ japanese society of neurology. treatment and management guideline 2018 for parkinson’s disease
² japan intractable diseases information center　

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced that latest data on lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of sleep-wake disorders, including insomnia and irregular sleep-wake rhythm disorder (iswrd) associated with alzheimer’s disease/dementia will be presented at world sleep congress (world sleep 2019), from september 20 to 25 in vancouver, canada.

at this congress, oral presentations will be given including the first congress presentation about the analysis of results at the end of 12 months from phase iii clinical study (sunrise-2) evaluating long-term effectiveness and safety of lemborexant in patients with insomnia and the effect on sleep architecture in older adults with insomnia from phase iii clinical study (sunrise-1) evaluating the efficacy and safety of lemborexant. furthermore, one more oral presentation for nonclinical research about efficacy of lemborexant with iswrd model mouse will be held. in addition, six poster presentations, including on the effect of lemborexant on fatigue by patient-reported outcomes from the 6-month placebo-controlled treatment period of sunrise-2 as a subgroup analysis will be given.

lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
lemborexant is being developed for the treatment of sleep-wake disorders including insomnia disorder, and eisai has submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the united states (december 2018), japan (march 2019), and canada (august 2019), respectively. additionally, a phase ii clinical study of lemborexant in patients with iswrd associated with mild to moderate alzheimer’s dementia is underway. for the ongoing clinical studies, please visit clinicaltrials.gov.

through the development of lemborexant, eisai aims for contribution for rework/recovery by bringing an active daytime life by fast sleep onset and good quality sleep to patients suffering from sleep-wake disorders including insomnia, and is striving to further contribute to satisfying unmet medical needs and improve the benefits to patients and their families.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

combination treatment approved for patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
under new fda-initiated program, combination treatment is the first to receive simultaneous review decisions in the u.s., australia and canada

tokyo, and kenilworth, n.j., [september 18, 2019] – eisai (ceo: haruo naito) and merck & co., inc., kenilworth, n.j., u.s.a. (nyse: mrk), known as msd outside the united states and canada, today announced that the u.s. food and drug administration (fda) approved the combination of lenvima, the orally available kinase inhibitor discovered by eisai, plus keytruda, merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. this marks the first u.s. approval for the combination of lenvima plus keytruda and the first time an anti-pd-1 therapy is approved in combination with a kinase inhibitor for advanced endometrial carcinoma in the u.s. following submission on june 17, this is an accelerated approval reviewed under the fda’s real-time oncology review (rtor) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible. rtor allows the fda to review much of the data earlier, before the applicant formally submits the complete application. this accelerated approval is based on tumor response rate and durability of response. continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. according to the fda, this review was conducted under project orbis, an initiative of the fda oncology center of excellence. project orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. under this project, the fda, the australian therapeutic goods administration (tga) and health canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

the approval was based on data from study 111/keynote-146, a phase 2, multi-cohort, multi-center, open-label, single-arm trial that enrolled 108 patients with metastatic endometrial carcinoma that had progressed following at least one prior systemic therapy in any setting. in the 94 patients with tumors that were not msi-h or dmmr, the lenvima plus keytruda combination demonstrated an orr of 38.3% (95% ci, 29-49), with a complete response rate of 10.6% (n=10) and a partial response rate of 27.7% (n=26). in the patients who had a response as determined by independent review (n=36), at the time of data cutoff, the median dor was not reached (range, 1.2 to 33.1 months), and 69% of these patients experienced responses lasting six months or longer. the most common adverse reactions (≥20%) with the lenvima plus keytruda combination were fatigue, musculoskeletal pain, hypertension, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough and rash.

“when diagnosed early, endometrial carcinoma can have a good prognosis; however, for women whose cancer has progressed following prior systemic therapy, there are few fda-approved treatment options,” said dr. vicky makker, medical oncologist, memorial sloan kettering cancer center. “based on objective response rate and the duration of response, this approval of the lenvima plus keytruda combination will help address a significant unmet medical need for patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.”

“today’s approval of the lenvima plus keytruda combination for advanced endometrial carcinoma that has progressed following prior systemic therapy brings the first approved combination treatment to women with this type of cancer whose tumors are not msi-h or dmmr and who are not candidates for curative surgery or radiation, and this demonstrates the potential of our collaboration with eisai,” said dr. jonathan cheng, vice president, oncology clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “merck & co., inc., kenilworth, n.j., u.s.a. is committed to developing this combination through the leap (lenvatinib and pembrolizumab) clinical program, which is under active investigation.”

“at least 75% of endometrial cancer cases are not microsatellite instability-high or mismatch repair deficient, and these women have been in need of new treatment options,” said dr. takashi owa, vice president, chief medicine creation and chief discovery officer, oncology business group at eisai. “we are very pleased that the lenvima plus keytruda combination for patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation has been selected for fda’s rtor pilot program, launched last year, and has been approved approximately three months after the submission. we look forward to providing this combination therapy to women with certain types of advanced endometrial carcinoma.”

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda.

in addition to ongoing clinical studies evaluating the keytruda plus lenvima combination across several different tumor types, the companies will jointly initiate new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program, which will evaluate the combination to support 11 potential indications in six types of cancer. the leap clinical program also includes a new basket trial targeting six additional cancer types.

the pivotal studies evaluating the combination therapy of lenvima plus keytruda in hepatocellular carcinoma (first-line), renal cell carcinoma (first-line), melanoma (first-line and second-line), non-squamous cell lung carcinoma (first-line [all-comer], first-line [pd-l1 positive] and second-line), endometrial carcinoma (first-line and second-line), and bladder carcinoma (first-line) are currently underway.

eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment with experience and knowledge from halaven and lenvima and the driver gene mutation and aberrant splicing leveraging rna splicing platform as areas (ricchi) where real patient needs are still unmet, and where eisai can become a frontrunner in oncology area. eisai will discover innovative new drug with new target and mechanism of action from these ricchi, and aims for contribution to cure cancers.

about eisai

eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. 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. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global), (for u.s.) or (for u.k.), and connect with us on twitter (. and ) and (for u.s.).

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer

our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, visit .

about merck & co., inc., kenilworth, n.j., u.s.a.

for more than a century, merck & co., inc., kenilworth, n.j., u.s.a., a leading global biopharmaceutical company known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. we also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. today, merck & co., inc., kenilworth, n.j., u.s.a. continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, alzheimer’s disease and infectious diseases including hiv and ebola. for more information, visit and connect with us on , , , and .

forward-looking statement of merck & co., inc., kenilworth, n.j., usa

this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2018 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

news – page 17 – eisai china lnc.-威尼斯人888

customer service hotline

links

more information