CAMBRIDGE, England,
August 8, 2017 /PRNewswire/ --
- Carfilzomib Accepted in Combination with Dexamethasone Alone
for the Treatment of Adult Patients with Multiple Myeloma who have
Received At least One Prior Therapy
- Patients Treated with Carfilzomib in Combination with
Dexamethasone Showed a Significant Increase in Progression-Free
Survival Compared to Bortezomib with Dexamethasone
- Carfilzomib is the First and Only Proteasome Inhibitor to
Demonstrate Statistically Significant Improved Overall Survival in
a Head-to-Head Trial
Today, the Scottish Medicines Consortium (SMC) has published its
advice accepting the use of KYPROLIS (carfilzomib) in combination
with dexamethasone alone for the treatment of adult patients with
multiple myeloma who have received at least one prior therapy. The
advice takes into account the continuing availability of the
Patient Access Scheme (PAS) agreed or a list price that is
equivalent or lower.[1]
(Logo:
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The SMC advice guides NHS Boards and Area Drug and Therapeutic
Committees (ADTCs) on the use of carfilzomib within NHS Scotland.
It has taken into account the views of patient group
representatives and clinical specialists in a Patient and Clinical
Engagement (PACE) meeting.[1]
"This is great news for patients in Scotland. The approval of carfilzomib and
dexamethasone for use on the NHS gives myeloma patients, whose
cancer has come back, an important new treatment option," said
Shelagh McKinlay, Policy and Public
Affairs Officer, Myeloma UK. "We are especially pleased that the
approval covers all patients who have had one prior treatment as
carfilzomib and dexamethasone has been shown to be very effective
in prolonging survival in relapsed myeloma patients, and should be
available to doctors as a prescribing option for their eligible
patients."
Clinical experts consulted by the SMC considered that
carfilzomib plus dexamethasone is a therapeutic advance as it
provides an opportunity to increase overall and progression-free
survival when compared to bortezomib plus dexamethasone; one of the
current standard of care for relapsed multiple myeloma. It also
concluded that carfilzomib is associated with a reduced rate of
peripheral neuropathy.[1]
The key evidence to support the use of carfilzomib in
combination with dexamethasone in the treatment of adults with
relapsed multiple myeloma 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 bortezomib plus dexamethasone (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]
"We are pleased with the outcome from the Scottish Medicines
Consortium, which follows the recent National Institute for Health
and Care Excellence's recommendation for carfilzomib. This means
that suitable patients in England,
Wales and Scotland will have access to a treatment with
proven evidence to prolong progression-free and overall survival,"
said Tony Patrikios, Executive
Medical Director at Amgen UK and Ireland. "We know that time free of disease is
precious and we are committed to advancing care for people with
this difficult-to-treat blood cancer. We see carfilzomib as the
backbone therapy for the management of relapsed multiple
myeloma."
In the UK, it is estimated that there are approximately 17,500
people living with myeloma[4] and it accounts for around
two percent of all cancers.[4] In
Scotland, it is estimated that
there are 473 new cases and 273 deaths due to multiple myeloma each
year.[5] It is estimated that over 1,300 patients will
be eligible for treatment rising to over 1,700 patients by year
five.[1]
Following the publication of the SMC's advice, NHS Boards in
Scotland now have a maximum of 60
days to include carfilzomib in their formularies for the treatment
of patients with multiple myeloma who have received at least one
prior therapy. The advice is contingent upon Amgen UK providing
carfilzomib to NHS Scotland within the terms of the agreed PAS.
Please refer to the Summary of Product Characteristics for full
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.[6] Carfilzomib has been shown to block
proteasomes leading to an excessive build-up of proteins within
cells.[7] Carfilzomib can cause cell death,
especially in myeloma cells because they are more likely to contain
a higher amount of abnormal
proteins.[7]
Important European Union Product Safety
Information for Carfilzomib
▼ This medicinal product is subject to additional monitoring.
Adverse events should be reported. Reporting forms and information
can be found at http://www.mhra.gov.uk/yellowcard . Adverse events
should also be reported to Amgen Limited on +44(0)1223-436441.
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] SMC Detailed Advice Document carfilzomib 10mg,
30mg, 60mg powder for solution for infusion (Kyprolis®). SMC No.
(1242/17). Available at: http://www.scottishmedicines.org.uk .
Accessed August 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] 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 August 2017.
[5] ISD Scotland Cancer Statistics Multiple Myeloma.
Available at:
http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Multiple-Myeloma/
Accessed August 2017.
[6] Moreau P, Richardson PG, Cavo M, et al.
Proteasome Inhibitors in Multiple Myeloma: 10 Years
Later. Blood. 2012; 120(5):947-959.
[7] Kyprolis® (carfilzomib). Summary of Product
Characteristics. December 20, 2016.
Available at https://www.medicines.org.uk/emc/medicine/31222 .
Accessed August 2017.