CAMBRIDGE, England,
April 27, 2017 /PRNewswire/ --
- National Institute for Health and Care Excellence (NICE)
Published a Final Appraisal Determination (FAD) in a Single
Technology Appraisal Reviewing BLINCYTO (blinatumomab)
- FAD Reinforces Significant Need for Innovative Treatment
Options for Patients With Relapsed or Refractory Acute
Lymphoblastic Leukemia (ALL)
- Blinatumomab is the First-and-Only Approved Bispecific
CD19-Directed CD3 T Cell Engager (BiTE®)
Immunotherapy
Today the National Institute for Health and Care Excellence
(NICE) has published its Final Appraisal Determination (FAD)
recommending BLINCYTO® (blinatumomab) as an option for
treating adults with Philadelphia-chromosome-negative (Ph-)
relapsed or refractory B-precursor acute lymphoblastic leukaemia
(ALL), on the basis of the discount agreed in the patient access
scheme. NICE reviewed the data available on the clinical and
cost-effectiveness of blinatumomab. Having considered evidence on
the nature of the disease and the value placed on the benefits of
blinatumomab by people with the condition, those who represent
them, and clinical experts, NICE concluded that it is a
cost-effective use of NHS resources under the end-of-life
criteria.[1]
(Logo:
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"Living with ALL, particularly when first line treatment has
failed, can have a profound impact on the person's physical and
psychological wellbeing. It can also place a big emotional strain
on their families and friends," said Zack
Pemberton-Whiteley from Leukaemia CARE. "For patients, the
knowledge that there are alternative treatments available can
provide some relief. We are pleased that NICE has recommended
blinatumomab to be made routinely available to patients in
England and Wales. This is consistent with a previous
decision from the Scottish Medicines Consortium, ending the
variations in access between England and Scotland."
Blinatumomab is a bispecific CD19-directed CD3 T cell engager
(BiTE®) antibody construct. It is the first bispecific
antibody construct
from Amgen's BiTE® platform, which helps
the body's immune system target cancer cells and represents an
entirely new area of authorised oncology therapeutics.
BiTE® antibody constructs are currently being
investigated for their potential to treat a wide variety of
cancers.
"I am absolutely delighted that blinatumomab will be available
for this population of patients with ALL. It's a step-change in how
we deliver therapies in this area; a new approach that activates a
patient's own immune system which is both more effective and less
toxic than standard chemotherapy," said Professor Adele Fielding, Professor of Haematology,
University College London. "I am proud that the UK was able to play
a key role in the international Phase 2 and 3 studies that led to
this approval; and of NICE for evaluating the clinical evidence
that is generated by such trials, for their transparent, rational
and fair approach to decision making."
The clinical evidence assessed by NICE focused on the Phase 3
TOWER study and Phase 2 MT 103-211 study. Results from the TOWER
study showed that median overall survival (OS) was 7.7 months (95
percent CI: 5.6, 9.6) for blinatumomab versus 4.0 months (95
percent CI: 2.9, 5.3) for standard of care chemotherapy (hazard
ratio [HR] for death=0.71; p=0.01).[2]
"Amgen is committed to ensuring patients in the UK get access to
effective therapies for hard-to-treat cancers like ALL. Patients
with relapsed or refractory ALL have an extremely poor prognosis
and we are pleased that NICE has recommended blinatumomab for
routine use on the NHS, giving patients and their physicians a
novel option to help manage their disease," said Tony Patrikios, Executive Medical Director,
Amgen UK and Ireland.
ALL is a rare and rapidly progressing cancer of the blood and
bone marrow, with around 760 new cases in the UK a
year.[3] Currently, there is no broadly accepted
standard treatment regimen for adult patients with relapsed or
refractory ALL beyond chemotherapy.[4] In adults,
approximately 75 percent is B-cell precursor ALL, of which 75-80
percent are Philadelphia-chromosome-negative, and roughly
half will be refractory to treatment or experience
relapse.[5]
In England, blinatumomab is
available with immediate effect via interim funding arrangements.
In Wales, medicines recommended by
NICE will be made available within two months of the publication of
the Final Appraisal Determination. Subject to NICE issuing positive
Final Guidance, interim funding for blinatunomab in England will be available until 90 days after
NICE Final Guidance is issued, whereupon funding will switch
permanently to baseline commissioning budgets. This guidance is
contingent upon Amgen UK providing blinatumomab to the NHS within
the terms of an agreed patient access scheme.
Please refer to the Summary of Product Characteristics for full
European prescribing information:
https://www.medicines.org.uk/emc/medicine/31231
About
BLINCYTO® (blinatumomab)
Blinatumomab is a bispecific CD19-directed CD3 T cell engager
(BiTE®) antibody construct that binds specifically to
CD19 expressed on the surface of cells of B-lineage origin and CD3
expressed on the surface of T cells.
In November 2015, BLINCYTO was
granted conditional marketing authorisation in the EU for the
treatment adults with Philadelphia
chromosome negative relapsed or refractory B-precursor acute
lymphoblastic leukaemia (ALL).
▼ Important EU Product Safety Information
This product is subject to additional
monitoring in the EU and EEA. All suspected adverse reactions
should be reported in accordance with the national reporting
system.
The adverse reactions described in this section were identified
in the Phase 2 MT 103-211 study (N=189).The most serious adverse
reactions that may occur during blinatumomab treatment include:
infections (31.7%), neurologic events (16.4%), neutropenia/febrile
neutropenia (15.3%) cytokine release syndrome (0.5%), and tumor
lysis syndrome (0.5%). The most common adverse reactions were:
infusion-related reactions (67.2%), infections (63.0%), pyrexia
(59.8%), headache (34.4%), febrile neutropenia (28%), peripheral
edema (25.9%), nausea (24.3%), hypokalemia (23.8%), constipation
(20.6%), anemia (20.1%), cough (18.5%), diarrhea (18.0%), tremor
(17.5%), neutropenia (17.5%), abdominal pain (16.9%), insomnia
(15.3%), fatigue (15.3%), and chills (15.3%).
About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs
are a type of immunotherapy being investigated for fighting cancer
by helping the body's immune system to detect and target malignant
cells. The modified antibodies are designed to engage two different
targets simultaneously, thereby juxtaposing T cells (a type of
white blood cell capable of killing other cells perceived as
threats) to cancer cells. BiTE® antibody constructs help
place the T cells within reach of the targeted cell, with the
intent of allowing T cells to inject toxins and trigger the cancer
cell to die (apoptosis). BiTE® antibody constructs are
currently being investigated for their potential to treat a wide
variety of cancers.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit http://www.amgen.co.uk.
References:
1. NICE Final Appraisal Documentation Blinatumomab for
previously treated Philadelphia-chromosome-negative acute
lymphoblastic leukemia. Available from:
https://www.nice.org.uk/guidance/gid-ta10093/documents/final-appraisal-determination-document
(Last Accessed April 2017)
2. Topp M, et al. Blinatumomab versus Chemotherapy for Advanced
Acute Lymphoblastic Leukemia. N Engl J Med 2017;
376:836-847
3. Cancer Research UK Acute lymphoblastic leukaemia (ALL)
incidence. Available from:
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-all#heading-Zero
(Last Accessed April 2017)
4. Davis T, Farag SS. Treating relapsed or refractor
Philedelphia chromosome-negative actuve lymphoblastic
leukemia : liposome-encapsulated vincristine. Int J
Nanomedicine. 2013;8:3479-88
5. Katz AJ, et al. Acute lymphoblastic leukemia: an assessment
of international incidence, survival, and disease burden. Cancer
Causes Control. 2015 Nov;26(11):1627-42