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EUSA Pharma today approved a decision of the National Institute of Health and
Clinical Excellence – NICE) to recommend the use of immunotherapy
against cancer, QARZIBA (dinutuximab beta) for
treating children with high-risk neuroblastoma in the national system of
(NHS) in England and Wales.
neuroblastoma an aggressive form of neuroblastoma – the
The most common solid tumor of childhood that comes from outside the brain.
Dinutuximab beta is the first approved cancer immunotherapy
for use in the NHS to treat this disease. It has been verified in an badysis
after the event, the improvement in overall survival (SG) results
comparison with historically treated patients who did not receive
immunotherapy as part of their treatments. Dinutuximab beta, when
used in the maintenance phase of treatment for patients who do not
received prior immunotherapy, also used to prevent this
return or progress in some children with high neuroblastoma.
risk.ii
"Today's NICE decision is an essential step in the treatment of children with this type of aggressive cancer," said Juliet Gray, a teacher.
badociated with pediatric oncology at the Center for Immunology of the
University of Southampton. "By taking advantage of the body's immune system, Dinutuximab beta has shown that it can target and attack this cancer very effectively in some patients, which can mean weeks or extra months with their families. for that they become cancer free for a long period of time. "
Dinutuximab beta is a monoclonal antibody (a type of protein) that
is linked to a specific target that is overexpressed
neuroblastoma, called GD2.iii This induces immune mechanisms
that allow the immune system to lead to the destruction of
neuroblastoma cells In the clinical study of
Phase III (APN311-302), a comparison after the event of dinutuximab beta,
used in the maintenance phase of the first-line treatment of
high risk neuroblastoma (n = 367), showed better results
survival rate, with a 12% improvement in 3-year OS
the use of immunotherapy in a historical control group of
patients (n = 450) .ii Patients treated with
dinutuximab beta had an SG rate of about 65% in 5 years
50% compared to the historical control group (p =
Tony Heddon, President of Neuroblastoma UK, commented: "To ensure that children and families with high-risk neuroblastoma have access to the medicines and care they absolutely need." Today's recommendation is a bold and innovative decision by NICE. For this reason, EUSA Pharma and all those who have worked together to make this medicine available. "This decision offers hope that these children with high-risk neuroblastoma may now have a better future."
On average, every week, two British families discover that
his son has neuroblastoma, with about 100 children diagnosed with
each year.iv the solid tumor that presents a larger
frequencies in children younger than one year, corresponding to
about one-fifth (22%) of all cancers diagnosed at this age.
Children with a high-risk disease, to whom this approval applies,
account for about 40% of all neuroblastoma cases.
Children with high-risk neuroblastoma often go through many
complex and intensive treatment periods, usually
several periods of chemotherapy, surgery, transplantation
stem cells and radiotherapy.vii
NICE's recommendation in its final evaluation decision
(Final Determination of Evaluation, FAD) that dinutuximab beta is
used as an option for the treatment of high-risk neuroblastoma
after at least a partial response of induction chemotherapy followed
of myeloablative therapy and stem cell transplantation in people
12 months and over if the person has not received previous immunotherapy
with anti-GD2.i
Lee Morley, executive director of EUSA Pharma, added: "Today's decision is the result of a close collaboration between NICE, EUSA Pharma and the neuroblastoma community. who have worked tirelessly to ensure that every child eligible Our long-term commitment has always been to ensure access to dinutuximab beta for all eligible children with high-risk neuroblastoma in all the UK, and the decision taken today is an essential part of this journey from Wales, we continue to work closely with the health authorities of Scotland and Ireland of North, in order to make these medicines available in these countries as quickly as possible. "
– FIM –
NOTES TO PUBLISHERS
About dinutuximab beta
How does it work
Dinutuximab beta is a monoclonal antibody (a type of protein) that
was designed to recognize and bind to a hydrate structure
badociated with the tumor, called GD2, which is present in large
amounts on the surface of neuroblastoma cells.
When dinutuximab beta binds to neuroblastoma cells, it induces
of the immune system (immune-mediated immune
complementary and antibody-dependent cells) and converts them to
target the body's immune system. Then prepare an attack
to kill cancer cells, using immune cells
of the body and the system of protein supplement.ii
Development and Approval
Dinutuximab beta the result of a thoughtful cooperation
Scientific-Pharmaceutical. Dinutuximab beta was developed by
Apeiron Biologics with a number of partnerships (including
clinical neuroblastoma SIOPEN) and acquired by EUSA Pharma in 2016,
to bring the treatment to the market. Beta-dinutuximab has received approval
Europe in May 2017, first under the brands Dinutuximab beta
Apeiron and Dinutuximab beta EUSA and in the sequence under its new name,
QARZIBA, approved by the European Medicines Agency in
November 2017.iii
How to use
Dinutuximab administered by the beta route by infusion
drop) into the vein. Each period of treatment with the drug
administered for 5 or 10 days every 35 days. administered by a
total of 5 periods. The recommended dose depends on the weight and height of the
patient.iii
Data to support its use
Dinutuximab beta has been studied in several clinical studies for
neuroblastoma.ii When evaluating NICE, the
APN311-302, a multinational study,
phase III open, randomized and controlled, comparing dinutuximab
beta in combination with isotretinone (n = 189) with dinutuximab beta
in combination with isotretinone and interleukin-2 (n = 190) .i, ii
main criterion of the study was the event-free survival in three years
(progression or recurrence of the disease, death and secondary tumor defined
as events) with SG, general response and incidence of refractory disease
or relapse included as secondary outcomes.
study included up to five different comparison phases, one of the
What was the treatment with dinutuximab beta with or without interleukin-2
(IL-2) during the maintenance phase, in the first line.
In the study APN311-302, three-year survival without event (end stage
primary) showed 55% levels without IL-2 and 61% with IL-2 (p = 0.3202),
while 3-year OS rates were 64% and 69%, respectively (p
= 0.6114) .i A comparison with a historical control group
obtained from a previous patient registry in the APN311-302 study (among
2002 and 2010) was performed in 450 patients with neuroblastoma
high risk, who has not received immunotherapy. Depending on the number of
relatively high number of patients, waiting for these patients
are representative of patients with high-risk neuroblastoma
observed in clinical practice during this period. This comparison
showed that the percentage of patients who were still alive after three
years of follow-up were 12% higher after treatment with dinutuximab
(with or without IL-2) only for patients who have not received
immunotherapy, a difference considered clinically relevant.
He also had an SG rate of about 65% in 5 years with
dinutuximab beta versus 50% in the historical control group (p =
In the marketing authorization, the European Medicines Agency
considered that the available data set was not complete and that
measures are needed to generate additional data on
Security. EUSA Pharma is committed to this and continues to
more data to expand the range of
information on this medication.ii
Side effects
Side effects with dinutuximab beta are common. In general,
more common side effects with dinutuximab beta (which can
affect more than 7 out of 10 people) are pyrexia (fever) and pain. Other
Side effects (which can affect more than 3 out of 10 people) are:
hypersensitivity (allergy), vomiting, diarrhea,
capillary leak (leakage of fluid from blood vessels
may cause swelling and falling of blood pressure) and hypotension (pressure
low blood pressure) .iii
In the APN311-302 study, 98.9% of patients (362 out of 366) of both groups
reported toxicities. Serious adverse events have been
reported more frequently in patients receiving IL-2 (46%
183 patients) compared to patients who did not receive IL-2 (27%
of 183 patients) The serious adverse events that caused the
treatment was more frequent in the IL2 group than in the non-IL2 group,
17% x 6% of patients, respectively.
More details on the side effects can be found in the
Summary of product characteristics on the website of the
Medicines (EMA) .viiihttp: //www.ema.europa.eu/ema/index.jsp? Curl = pages / medicines / human / medicines / 003918 / human_med_002104.jsp & mid; = wc0b01ac058001d124
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a pharmaceutical company
with commercial operations in Europe and the United States and a wide range of
distribution network in around 40 countries around the world. The team of
gesture formed by very experienced pharmacists,
with a proven track record of success in identifying, developing
and commercialization of innovative medicines that promote health care
to the patient and improve his well-being. For more information, visit: http://www.eusapharma.com.
References
Final Evaluation Determination (FAD) for dinutuximab
beta for the treatment of neuroblastoma.
ii QARZIBA public evaluation report. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_badessment_report/human/003918/WC500227726.pdf
Accessed in July 2018
iii QARZIBA EPAR – Summary for the public. Available at: http://www.eme.gov.au
Accessed in July 2018
iv Cancer Research UK: About Neuroblastoma. Main facts
available at: https://bit.ly/2NjdR2b
Accessed in July 2018.
v Cancer Research UK: Infantile Cancers. SNS for children
tumor incidence. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/childrens-cancers/incidence#heading-Eleven
Accessed in July 2018.
vi NICE dinutuximab beta committee documents. Available at: https://www.nice.org.uk/guidance/gid-ta10069/documents/committee-papers
Accessed in July 2018.
vii Cancer Research UK – treatment of neuroblastoma by risk
group. Key facts available at: https://www.cancerresearchuk.org/about-cancer/childrens-cancer/neuroblastoma/treatment-risk-group
Accessed in July 2018.
viii QARZIBA SmPC – Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003918/WC500227724.pdf
Accessed in July 2018.
? This medicine is subject to additional control. This
enable the rapid identification of new security information.
Adverse events must be reported. Forms of communication and
information can be found at www.mhra.gov.uk/yellowcardreporting.
Adverse events must also be reported EUSA Pharma. E-mail: [email protected]
Fax: +44 (0) 3305 001167
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