CAMBRIDGE, England,
June 13, 2017 /PRNewswire/ --
- National Institute for Health and Care Excellence (NICE)
Published a Final Appraisal Determination (FAD) in a Single
Technology Appraisal Reviewing
KYPROLIS® (Carfilzomib)
- Carfilzomib Recommended as An Option for Treating Adults with
Relapsed Multiple Myeloma Who Have Received One Prior Therapy That
Does Not Include Bortezomib (Velcade®)
Today, the National Institute for Health and Care Excellence
(NICE) has published its Final Appraisal Determination (FAD)
recommending carfilzomib in combination with dexamethasone as an
option for treating adults with relapsed multiple myeloma (RMM) who
have received one prior therapy that does not include bortezomib.
This recommendation is based on the discount agreed in the patient
access scheme.[1]
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During the Health Technology Assessment, NICE, alongside
patients, Myeloma UK, and healthcare professionals, recognised
carfilzomib as a much needed treatment option after relapse and a
cost-effective use of NHS resources.[1]
"It is great news that carfilzomib, in combination with
dexamethasone, has been approved by NICE. The decision means that
myeloma patients who have not previously received bortezomib will
have the option of accessing a new and effective proteasome
inhibitor at first relapse," said Kate
Morgan, Policy and Public Affairs Manager, Myeloma UK. "As
carfilzomib and dexamethasone has been shown to be effective in
prolonging survival in relapsed myeloma patients, with limited
negative impact on quality of life, it is very important for
patients to have access to it on the NHS."
NICE heard from a patient expert that people taking carfilzomib
find the treatment tolerable and that it does not appear to be
associated with neuropathic adverse reactions to the same extent as
standard treatment. The NICE committee concluded there is a need
for effective treatment options after relapse and that patients and
clinicians would like to have access to carfilzomib because it
offers quality-of-life improvements over current treatment
options.[1]
"Clinical trial data have proven that, in combination with
dexamethasone, carfilzomib is superior to bortezomib, having
doubled progression-free survival and significantly improved
overall survival for patients who have relapsed," said Professor
Graham Jackson, Consultant
Haematologist, Freeman Hospital, Newcastle. "With the relapsing and progressive
nature of multiple myeloma, there is a high unmet need for more
effective treatments, and as a clinician, I am encouraged to see
advances being made that may benefit my patients."
"We have worked collaboratively with NICE to identify and submit
an optimal submission package for carfilzomib and we are very
pleased with the outcome today," said Tony
Patrikios, Executive Medical Director at Amgen UK and
Ireland. "With proven evidence to
prolong progression-free survival, we see carfilzomib as backbone
therapy for the management of relapsed multiple myeloma. We know
that time free of disease is precious and are committed to
advancing care for people with this difficult-to-treat blood
cancer."
The key evidence to support the use of carfilzomib in
combination with dexamethasone in the treatment of adults with RMM,
was based on the large Phase 3 randomised study, ENDEAVOR (n=929).
This first ever head-to-head clinical trial comparing two
proteasome inhibitors showed that adults treated with carfilzomib
plus dexamethasone lived almost twice as long without their cancer
progressing (progression-free survival; PFS) compared to adults who
received bortezomib plus dexamethasone, the current standard of
care (18.7 months vs. 9.4 months).[2] Moreover, in
a planned interim analysis of overall survival (OS), carfilzomib
and dexamethasone (Kd) reduced the risk of death by 21 percent
compared to bortezomib and dexamethasone (Vd), resulting in a 7.6
month survival benefit (median OS 47.6 months for Kd versus 40.0
for Vd, HR=0.79; 95 percent CI: 0.65 - 0.96;
p=0.01).[3] These benefits were also observed in
the subgroup considered by NICE, in patients who have received one
prior therapy and no prior bortezomib.[2]
Together with ENDEAVOR, data from the Phase 3 randomised study,
ASPIRE (n=792) were also reviewed. The study showed that
carfilzomib with lenalidomide and dexamethasone (KRd) was effective
at prolonging progression-free survival, compared with lenalidomide
and dexamethasone (Rd) alone in patients with relapsed multiple
myeloma (26.3 months KRd vs 17.6 Rd).[4] NICE
considered KRd compared to Rd in patients at first relapse who had
received prior bortezomib, and in patients who had received two or
more prior lines of therapy, but did not recommend KRd for either
of these groups of patients.[1]
In the UK, it is estimated that there are approximately 17,500
people living with myeloma[5] and it accounts for
around two percent of all cancers.[5] With
approximately 5,500 new cases diagnosed each
year,[5] the UK incidence rate is ninth highest in
Europe for males and eight highest
for females.[6] The UK registry data suggests that
on relapse, median survival is less than two years from the start
of second-line therapy and around one year from the start of
third-line therapy.[7]
Carfilzomib is available with immediate effect via interim
funding arrangements in England
and in Wales. Subject to NICE
issuing positive Final Guidance, interim funding for carfilzomib 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 carfilzomib 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/31222
About carfilzomib (KYPROLIS®) for
Injection
Carfilzomib is an irreversible proteasome inhibitor for use in
the treatment of adults with multiple myeloma after one prior
treatment. Proteasomes play an important role in cell function
and growth by breaking down proteins that are damaged or no longer
needed.[8] Carfilzomib has been shown to block
proteasomes leading to an excessive build-up of proteins within
cells.[9] Carfilzomib can cause cell death,
especially in myeloma cells because they are more likely to contain
a higher amount of abnormal proteins.[9]
Important European Union Product
Safety Information for Carfilzomib
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
Carfilzomib treatment should be supervised by a physician
experienced in the use of anti-cancer therapy. The most serious
side effects that may occur during carfilzomib treatment include
cardiac toxicity, pulmonary toxicities, pulmonary hypertension,
dyspnoea, hypertension including hypertensive crises, acute renal
failure, tumour lysis syndrome, infusion reactions,
thrombocytopenia, hepatic toxicity, posterior reversible
encephalopathy syndrome (PRES) and thrombotic thrombocytopenic
purpura/haemolytic uremic syndrome (TTP/HUS).
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 Determination: Carfilzomib for
previously treated multiple
myeloma. https://www.nice.org.uk/guidance.
Accessed June 2017.
2. Dimopoulos, Meletios A et al.
Carfilzomib and dexamethasone versus bortezomib and dexamethasone
for patients with relapsed or refractory multiple myeloma
(ENDEAVOR): a randomised, phase 3, open-label, multicentre
study. The Lancet Oncology.
2016;17(1):27-38.
3. Dimopoulos, Meletios A et al. Overall
Survival of Patients with Relapsed or Refractory Multiple Myeloma
Treated with Carfilzomib and Dexamethasone versus
Bortezomib and Dexamethasone in the Randomized Phase 3 ENDEAVOR
Trial. Abstract: 16th International Myeloma Workshop. March 2017.
4. Stewart KA, Rajkumar VS, Dimopoulos MA, et
al. Carfilzomib, Lenalidomide, and Dexamethasone for
Relapsed Multiple Myeloma. N Engl J Med. 2015;
372:142-152.
5. Myeloma UK - Myeloma: Essential Guide. Available
at: https://www.myeloma.org.uk/wp-content/uploads/2013/09/Myeloma-UK-Living-well-with-Myeloma-Essential-Guide.pdf .
Accessed May 2017.
6. Cancer Research UK. Myeloma statistics. Available
at http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma#heading-Zero.
Accessed May 2017.
7. Amgen data on file. 2016.
8. Moreau P, Richardson PG, Cavo M, et
al. Proteasome Inhibitors in Multiple Myeloma: 10 Years
Later. Blood. 2012;
120(5):947-959
9. KYPROLIS® (carfilzomib).
Summary of Product Characteristics. December
20, 2016. Available
at https://www.medicines.org.uk/emc/medicine/31222 Accessed
May 2017.