HEMEL HEMPSTEAD, ENGLAND--( / ) July 12, 2018 -- EUSA Pharma today welcomed a decision by the National Institute for Health and Care Excellence (NICE) to recommend the use of the targeted cancer immunotherapy, QARZIBA® (dinutuximab beta) to treat children with high-risk neuroblastoma within the NHS in England and Wales.i High-risk neuroblastoma is an aggressive form of neuroblastoma - the most common solid tumour of childhood that originates outside of the brain.ii Dinutuximab beta is the first targeted cancer immunotherapy approved for use on the NHS to treat this disease. It has been shown in a post-hoc analysis to improve overall survival (OS) outcomes compared to historically treated patients who did not receive immunotherapy as part of their care. Dinutuximab beta, when used in the maintenance phase of treatment for patients who did not receive prior immunotherapy, is also used to keep this cancer from returning or progressing in some children with high-risk neuroblastoma.ii
“Today’s decision by NICE is a vital step forward in the treatment of young children with this aggressive type of cancer,” said Dr Juliet Gray, Associate Professor in Paediatric Oncology at the Cancer Immunology Centre, University of Southampton. “By harnessing the body’s own immune system, dinutuximab beta has shown it can target and attack this cancer very effectively in some patients. For some children this could mean extra weeks or months with their families, for others it may even lead to them becoming cancer-free for a long period of time.”
Dinutuximab beta is a monoclonal antibody (a type of protein) that binds to a specific target which is overexpressed on neuroblastoma cells, called GD2.iii This induces dual immune mechanisms that then enable the immune system to lead the destruction of neuroblastoma cancer cells.ii In the key phase III clinical study (APN311-302), a post hoc comparison of dinutuximab beta, used in the maintenance phase of the first-line treatment of high-risk neuroblastoma (n=367) , showed improved survival outcomes, with a 12% improvement in OS rate at three years versus using no immunotherapy in a historical control group of similar patients (n=450).ii The dinutuximab beta treated patients had an OS rate of around 65% at 5 years versus 50% compared to the historical control group (p=<0.0001).ii
Tony Heddon, Chair of Neuroblastoma UK commented: “Ensuring that children and families facing high-risk neuroblastoma have access to the medicines and care they need is absolutely critical. Today’s recommendation is a bold and forward-thinking decision from NICE and we applaud them, EUSA Pharma and all those across the community who have worked together to make this medicine available. This decision offers the hope that these children with high-risk neuroblastoma, may now have a better future in front of them.”
On average, every week, two families in the UK will learn that their child has neuroblastoma, with approximately 100 children diagnosed each year.iv It is the most frequently-occurring solid tumour in infants under the age of one, accounting for around a fifth (22%) of all cancers diagnosed at this age.v Children with high-risk disease to whom this approval applies, account for approximately 40% of all neuroblastoma cases.vi Children with high-risk neuroblastoma typically undergo many rounds of complex and intensive treatment, usually comprising several cycles of chemotherapy, surgery, stem cell transplant and radiotherapy.vii
The recommendation from NICE within its Final Appraisal Determination (FAD) is that dinutuximab beta be used as an option for treating high-risk neuroblastoma after at least a partial response from induction chemotherapy, followed by myeloablative therapy and stem cell transplant in people aged 12 months and over, if the person has not had previous anti-GD2 immunotherapy.i
Lee Morley, CEO of EUSA Pharma added: “Today’s decision is the result of strong collaboration between NICE, EUSA Pharma and the neuroblastoma community, who have each worked tirelessly to ensure that every eligible child has the option to benefit from this potentially life-changing treatment. Our long-standing commitment has always been to secure access to dinutuximab beta for all eligible children with high-risk neuroblastoma, across the UK and today’s decision is a key part of that journey. Beyond England and Wales, we are continuing to work closely with the Scottish and Northern Irish health authorities with the aim of making this medicine available in those countries as quickly as possible.”
About dinutuximab beta
How it works
Dinutuximab beta is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a tumour-associated carbohydrate structure, called GD2, which is present in high amounts on the surface of neuroblastoma cells.ii When dinutuximab beta attaches to the neuroblastoma cells, it induces dual immune system mechanisms (the complement-dependant and antibody-dependant cell-mediated immune pathways) and makes them a target for the body’s immune system. This then mounts an attack to kill the cancer cells, using the body’s natural killer immune cells, and the complement protein system.ii
Its development and approval
Dinutuximab beta is the result of a considered science-pharma collaboration. Dinutuximab beta was developed by Apeiron Biologics with a number of partners (in particular the SIOPEN academic neuroblastoma group) and acquired by EUSA Pharma in 2016, to bring the treatment to market. Dinutuximab beta received European approval in May 2017, first under the brand names dinutuximab beta Apeiron and Dinutuximab beta EUSA and subsequently under its new name, QARZIBA®, approved by the European Medicines Agency in November 2017.iii
How it is taken
Dinutuximab beta is given as an infusion (drip) into a vein. Each course of treatment with the medicine is given for 5 or 10 days every 35 days. It is given for a total of 5 courses. The recommended dose depends on the patient’s weight and height.iii
Data supporting its use
Dinutuximab beta has been investigated in a number of clinical trials for high-risk neuroblastoma.ii During the NICE appraisal, the primary clinical evidence came from APN311-302, a multinational, open-label, randomised, controlled Phase III trial comparing dinutuximab beta plus isotretinoin (n=189) with dinutuximab beta plus isotretinoin plus interleukin-2 (n=190).i,ii The primary outcome in the trial was event-free survival at three years (disease progression or relapse, death and secondary tumour defined as events) with OS, overall response, and incidence of relapsed or refractory disease included as secondary outcomes.ii This study consisted of up to five different comparison phases, one of which was treatment with dinutuximab beta with or without interleukin-2 (IL-2) during the maintenance phase , in the first line setting.ii
In APN311-302, the 3-year event free survival (primary endpoint) showed rates of 55% without IL-2 and 61% with IL-2 (p=0.3202) while the 3-year OS rates were 64% and 69%, respectively (p=0.6114).i A comparison to an historical control group obtained from an earlier patient enrolment within the APN311-302 study (between 2002 and 2010) was performed using 450 high-risk neuroblastoma patients, who did not receive immunotherapy. Given the relatively high number of patients it is expected that these patients are representative of patients with high-risk neuroblastoma seen in clinical practice during this period. This comparison showed that the percentage of patients that were still alive after three years of follow-up was 12% higher after dinutuximab beta treatment (with or without IL-2) than for patients who did not receive immunotherapy, a difference considered clinically relevant.ii It also showed an OS rate of around 65% at 5 years with dinutuximab beta versus 50% in the historical control group (p=<0.0001).ii
At marketing authorisation, the European Medicines Agency considered that the available data set was not comprehensive and that measures were necessary to generate additional efficacy and safety data. EUSA Pharma is committed to this and is continuing to collect further data to widen the body of efficacy and safety information available on this medicine.ii
Side effects with dinutuximab beta are common. In general, the most common side effects with dinutuximab beta (which may affect more than 7 in 10 people) are pyrexia (fever) and pain. Other side effects (which may affect more than 3 in 10 people) are hypersensitivity (allergy), vomiting, diarrhoea, capillary leak syndrome (leakage of fluid from blood vessels that can cause swelling and a drop in blood pressure) and hypotension (low blood pressure).iii
In the APN311-302 study, 98.9% of patients (362 of 366) in both treatment group experienced toxicities. Serious adverse events were reported more frequently in patients receiving IL-2 (46% of 183 patients) compared to patients not receiving IL-2 (27% of 183 patients). Serious adverse events leading to discontinuation of treatment were more frequent in the IL2 arm than the group without IL2,17% vs 6% of patients, respectively.ii
Further details of side effects can be found in the Summary of Product Characteristics on the EMA websiteviii
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations across Europe and the USA and a wider distribution network in approximately 40 further countries. The management team comprises highly-experienced pharmaceutical professionals with a proven track record of successfully identifying, developing and commercialising innovative medicines that advance patient care and improve their wellbeing. For more information visit:
i NICE Final Appraisal Determination (FAD) for dinutuximab beta for treating neuroblastoma.
ii QARZIBA Public Assessment Report. Available at Accessed July 2018
iii QARZIBA EPAR - Summary for the public. Available at Accessed July 2018
iv Cancer Research UK: About Neuroblastoma. Key fact available at Accessed July 2018.
v Cancer Research UK: Children’s cancers. Children’s SNS tumour incidence. Available at Accessed July 2018.
vi NICE dinutuximab beta committee papers. Available at Accessed July 2018.
vii Cancer Research UK - neuroblastoma treatment by risk group. Key fact available at Accessed July 2018.
viii QARZIBA SmPC - Available at Accessed July 2018.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to EUSA Pharma. Email: firstname.lastname@example.org Fax: +44(0)3305 001167
View source version on businesswire.com:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network
CHICAGO--() February 04, 2014 -- Heidrick & Struggles International, 이서영 WWW.ENLOTTO.CO.KR Inc.() 이서영 옛날만화 (Nasdaq:HSII), the premier professional services firm focused on serving the leadership needs of top organizations globally, today announced 야사랑 이토준지만화 that Tracy R. Wolstencroft has been named President and Chief Executive Officer. He has also joined 모모세코코아 CHICAGO--()Heidrick & Struggles Board of Directors. Jory Marino, who has been serving 이서영 2000년대만화 as Interim CEO, will continue with the firm in a leadership role.
Wolstencroft, 55, joins Heidrick & Struggles following a 25-year career at Goldman, Sachs & Co. A partner at Goldman 바비쮸우 Wolstencroft,1994 to 2010, he served on the Firmwide Partnership Committee, the Investment Banking Operating Committee, and the Asia Management Committee. During his career, he led a wide range of businesses in the United States and 야사랑 로또인생역전 abroad, including Investment Banking Services, Environmental 야사랑 스패니쉬 플라이 Markets, Latin America, Public Sector and 이서영 로또분석기 Infrastructure Banking, and Fixed Income Capital Markets. While living in Asia from 1998 to 2002, Wolstencroft was President of GS Singapore, co-head of investment banking 야사랑 로또추천사이트 in Japan, head of Asia financial institutions, and a leader of the firm's strategy in China. In 2010, he retired from the firm, becoming an Advisory Director and Chairman of the Clean Technology and Renewables business. He currently serves on the Boards of the Brookings Institution, the National Geographic Society, and the International Rescue Committee.
Richard Beattie, Chairman of the Board of Heidrick & Struggles, said, “Tracy Wolstencroft is a multi-talented executive who brings strong 야사랑 leadership capabilities and a proven ability to manage a global client-service organization. Tracy 이서영 실데나필 구입 방법 embodies all of the characteristics we were looking for in our 이서영 next CEO, and we are confident that our clients, employees and shareholders will benefit from his perspective, capabilities and commitment to excellence. He has an extensive global network, deep boardroom experience, and an outstanding reputation for delivering good counsel to senior leaders and organizations across a wide range of industries and geographies. We believe he is a great cultural fit and are delighted 토토넷 Richardhave 이서영 마취크림 him join Heidrick & Struggles.”
Beattie added, “On behalf of the entire Board and organization, I want to thank Jory Marino, a key member of the 야사랑 복제약종류 이서영 복제약종류 senior 지성 Beattieteam, for his important contributions to the firm 베이글비비 Beattiethis interim 야사랑 period. We are pleased we will continue to benefit 야사랑 바르는약 이서영 바르는약 from Jory's talents and expertise as he continues in a leadership role.”
Wolstencroft said, “Heidrick & Struggles has a great franchise and a premium brand, 나쁜토끼영상관 WolstencroftI look forward to working with its talented team to help the firm MS-ONLINE Wolstencroftits full potential. My focus will be on sharpening our strategy, energizing the team, fostering collaboration and teamwork, and building on our talent while increasing efficiency. We will drive innovation across the organization to ensure our global client base receives 이서영 the unparalleled expertise and service it needs 이서영 즉석복권스피또 to help build winning leadership teams. At 야사랑 the same time, we will be focused on leveraging an iconic brand to deliver significant long-term value to shareholders. I firmly believe in the power of this unique organization and that 바바라티비TV Wolstencroftbest days lie ahead.”
About 야사랑 로또899회당첨번호 Heidrick 이서영 그린로또 바바라티비TV AboutStruggles 이서영 해피그라정 International, Inc.
Heidrick & Struggles International, Inc. (Nasdaq:HSII) is the premier provider of senior-level Executive Search, Culture Shaping 바바라티비TV HeidrickLeadership Consulting services. For 60 years, we have focused on quality service and built strong leadership teams through our relationships with clients and individuals worldwide. Today, 호주복권 Heidrick& Struggles' leadership experts operate from principal business centers in North America, Latin 여자나체 HeidrickEurope and Asia Pacific. For 이서영 more information about Heidrick & 이서영 로또사자 Struggles, please 야사랑 로또커뮤니티 visitKorea Newswire distributes your news across every media 이서영 골드드래곤정 channels through the industry’s largest press release distribution network
|전화번호 :||영업시간 :|
|홈페이지 :||위치정보 :|
등록된 댓글이 없습니다.