THOUSAND OAKS, Calif.,
June 10, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced results from a post-hoc
analysis of the pivotal Phase 3 ASPIRE study which highlighted the
benefit of continued treatment with Kyprolis®
(carfilzomib) in combination with lenalidomide and dexamethasone
(KRd) in patients with relapsed multiple myeloma. Separate
sub-analyses of the Phase 3 ENDEAVOR study further confirmed
efficacy and depth of response benefits of Kyprolis plus
dexamethasone (Kd). These results were presented at the
21st Congress of the European Hematology Association
(EHA).
Results from the ASPIRE analysis showed that cumulative rates of
complete response or better (>CR) continued to increase over
time in the KRd arm, most quickly in the first 15 months of
treatment. In addition, the progression-free survival (PFS) hazard
ratio (HR) at 18 months was 0.58 (95 percent CI: 0.46-0.72),
while the overall study HR at 31 months was 0.69 (95 percent
CI: 0.57-0.83), possibly related to patients in the KRd arm
receiving Kyprolis for a maximum of 18 months (EHA abstract #P275).
Researchers assessed PFS HR at 18 months following discontinuation
of Kyprolis treatment in the KRd arm per the trial protocol. The
most common all grade treatment-related adverse events in the
ASPIRE trial included neutropenia (34.2 percent), anemia (25.5
percent), fatigue (22.4 percent) and thrombocytopenia (22.4
percent).
Six additional abstracts presented at EHA further demonstrate
the benefit of Kyprolis-based regimens across a range of patient
populations:
- Data analyzed in four presentations across patient subgroups
from the Phase 3 ENDEAVOR trial showed that patients with relapsed
or refractory multiple myeloma who were treated with Kd achieved
superior PFS compared to those receiving bortezomib plus
dexamethasone (Vd). The subgroup analyses evaluated the Kyprolis
combination based on prior treatment, cytogenetic risk status, age
and in Asian patients, respectively (EHA abstracts #E1266, #E1267,
#E1274 and #E1328).
- A secondary analysis of data from the Phase 3 ENDEAVOR study
found treatment with Kd compared to subcutaneous bortezomib led to
prolonged PFS regardless of prior bortezomib treatment. The results
suggest Kd has a favorable benefit-risk profile and delivers
superior efficacy and improved clinical outcomes (EHA abstract
#P659).
- A separate presentation analyzed the efficacy and safety of
Kyprolis according to baseline cytogenetic risk status, based on
data from the Phase 3 ASPIRE trial in which KRd demonstrated a
significant improvement in PFS compared to lenalidomide and
dexamethasone alone (EHA abstract #P663).
"This week's presentations at EHA continue to confirm that
compared to previous standard of care therapies, across patient
populations and therapeutic combinations, treatment with Kyprolis
can extend the time patients live without their disease
progressing," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "This abundant clinical research provides substantive,
meaningful evidence for Kyprolis as a foundational therapy for
relapsed or refractory multiple myeloma patients."
Abstracts are currently available on the EHA website.
EHA Abstract #P275:
Carfilzomib, Lenalidomide, and
Dexamethasone Versus Lenalidomide and Dexamethasone in Patients
with Relapsed Multiple Myeloma: Analysis of Response and
Progression-Free Survival Hazard Ratio Over Time
In this
post-hoc analysis of data from the Phase 3 ASPIRE trial,
researchers evaluated the time to cumulative >CR and PFS HR at
18 months from randomization for KRd-treated patients (n=396)
versus Rd-treated patients (n=396). KRd and Rd patients were
followed for a median of 31 and 30 months for PFS, respectively.
Per trial protocol, Kyprolis was discontinued after 18 cycles (28
days/cycle), so optimal duration of KRd treatment was not
determined. All patients continued to receive Rd treatment until
disease progression.
- A total of 126 and 37 patients in the KRd and Rd groups
achieved ≥CR with sample median time from treatment start to ≥CR of
6.7 and 8.3 months, respectively. The increase in rate of ≥CR
patients over time was greater in the KRd group than the Rd group,
most notably in the first 15 months; cumulative ≥CR rates increased
steadily thereafter.
- The overall PFS HR in ASPIRE for KRd versus Rd was 0.69 (95
percent CI: 0.57-0.83). For the first 18 months, the PFS HR was
0.58 (95 percent CI: 0.46-0.72). The 18-month PFS HR was lower than
the overall study PFS HR, possibly related to KRd patients
receiving Kyprolis for a maximum of 18 months.
- The most common all grade treatment-related adverse events in
the ASPIRE trial included neutropenia (34.2 percent), anemia (25.5
percent), fatigue (22.4 percent) and thrombocytopenia (22.4
percent).
EHA Abstract #E1266: Carfilzomib and Dexamethasone Versus
Bortezomib and Dexamethasone: Subgroup Analysis of the Phase 3
ENDEAVOR Study to Evaluate the Impact of Prior Treatment on
Patients with Relapsed Multiple Myeloma
This subgroup
analysis evaluated treatment with Kd versus Vd in patients after
first relapse versus more than two prior lines of therapy, as well
as the effect of previous exposure to bortezomib or
lenalidomide.
- For patients with prior bortezomib exposure, median PFS for Kd
compared to Vd was 15.6 months versus 8.1 months, respectively (HR:
0.56; 95 percent CI: 0.44-0.73). For patients without prior
bortezomib exposure, median PFS was not estimable (NE) for the
Kd-treated patients versus 11.2 months for Vd-treated patients (HR:
0.48; 95 percent CI: 0.36-0.66). In patients with prior bortezomib
exposure, overall response rates (ORRs) were 71.2 percent for Kd
versus 60.3 percent for Vd (OR: 1.63; 95 percent CI: 1.12-2.36) and
83.6 percent for Kd compared to 65.3 percent for Vd (OR: 2.72; 95
percent CI: 1.72-4.31) in patients without prior bortezomib
exposure.
- For patients with prior lenalidomide exposure, median PFS for
Kd-treated patients was 12.9 months compared to 7.3 months for
Vd-treated patients (HR: 0.69; 95 percent CI: 0.52-0.92). For
patients without prior lenalidomide exposure, median PFS for
Kd-treated patients was 22.2 months compared to 10.2 months for
Vd-treated patients (HR: 0.43; 95 percent CI: 0.32-0.56). For
patients with prior lenalidomide exposure, ORRs were 70.1 percent
for Kd versus 59.3 percent for Vd (OR: 1.60; 95 percent CI:
1.03-2.49), and 81.2 percent for Kd versus 64.6 percent for Vd (OR:
2.37; 95 percent CI: 1.62-3.47) in patients without prior
lenalidomide exposure.
- In patients with one prior line of therapy, grade 3 or higher
adverse events were reported in 69.8 percent of patients in the Kd
arm and 63.9 percent of patients in the Vd arm. In patients with
two or more prior lines of therapy, grade 3 or higher adverse
events were reported in 76.6 percent of patients in the Kd arm and
69.9 percent of patients in the Vd arm.
EHA Abstract #E1267: Carfilzomib and Dexamethasone Versus
Bortezomib and Dexamethasone: Subgroup Analysis of Patients with
Relapsed Multiple Myeloma by Baseline Cytogenetic Risk Status
(Phase 3 ENDEAVOR Study)
This pre-planned subgroup analysis
evaluated the efficacy and safety outcomes in patients treated with
Kd versus Vd according to patients' baseline cytogenetic risk
status.
- In the high-risk group, median PFS was 8.8 months (95 percent
CI: 6.9-11.3) for Kd-treated patients (n=97) versus 6.0 months for
Vd-treated patients (n=113) (95 percent CI: 4.9-8.1) (HR: 0.646; 95
percent CI: 0.453-0.921). ORRs (≥ partial response) were 72.2
percent for Kd-treated patients versus 58.4 percent for Vd-treated
patients. Median duration of response was 10.2 months for Kd versus
8.3 months for Vd.
- In the standard-risk group, median PFS was NE (95 percent CI:
18.7-NE) for Kd-treated patients (n=284) compared to 10.2 months
(95 percent CI: 9.3-12.2) for Vd-treated patients (n=291) (HR:
0.439; 95 percent CI: 0.333-0.578). ORRs were 79.2 percent for
Kd-treated patients versus 66.0 percent for Vd-treated patients.
Median duration of response was NE for Kd versus 11.7 months for
Vd.
- Grade 3 or higher adverse events were reported at higher rates
with Kd versus Vd in both the high and standard-risk groups (70.1
percent versus 63.1 percent and 73.9 percent versus 68.3 percent,
respectively).
EHA Abstract #E1274: Carfilzomib and Dexamethasone Versus
Bortezomib and Dexamethasone in Patients with Relapsed Multiple
Myeloma: Analysis of the Phase 3 ENDEAVOR Study by Age
Subgroup
This pre-planned subgroup analysis evaluated
results of the ENDEAVOR study according to patients' age (younger
than 65, 65-74, and 75 and older). Of the 929 patients enrolled,
223 patients received Kd and 210 received Vd in the <65 years
subgroup; 164 patients received Kd and 189 received Vd in the 65-74
years subgroup; and 77 patients received Kd and 66 received Vd in
the ≥75 years subgroup.
- For patients younger than 65 years, median PFS was NE for
Kd-treated patients compared to 9.5 months for Vd-treated patients
(HR: 0.58; 95 percent CI: 0.44-0.77). ORRs were 74 percent in the
Kd arm versus 61 percent in the Vd arm (OR: 1.82; 95 percent CI:
1.21-2.74).
- For patients aged 65–74 years, median PFS was 15.6 months for
Kd-treated patients versus 9.5 months for Vd-treated patients (HR:
0.53; 95 percent CI: 0.38-0.73). ORRs were 77 percent in the Kd arm
versus 66 percent in the Vd arm (OR: 1.80; 95 percent CI:
1.12-2.89).
- For patients aged 75 years and older, median PFS was 18.7
months for Kd-treated patients versus 8.9 months for Vd-treated
patients (HR: 0.38; 95 percent CI: 0.23-0.65). ORRs were 84 percent
in the Kd arm versus 59 percent in the Vd arm (OR: 3.75; 95 percent
CI: 1.71-8.24).
- Grade ≥3 hypertension, dyspnea, cardiac failure, renal failure
were more common with Kd versus Vd. Deaths within 30 days
post-study drug due to adverse events occurred.
EHA Abstract #E1328: Outcomes for Asian Patients With
Relapsed Multiple Myeloma Treated With Carfilzomib and
Dexamethasone Versus Bortezomib and Dexamethasone: A Subgroup
Analysis of the Phase 3 ENDEAVOR Study
This pre-planned
subgroup analysis evaluated the efficacy and safety outcomes in
Asian patients (n=109) with relapsed multiple myeloma from the
ENDEAVOR study. The majority of patients were from Japan (n=44; 40.4 percent), followed by
Taiwan (n=24; 22.0 percent),
Singapore (n=20; 18.3 percent),
Republic of Korea (n=16; 14.7 percent), and Thailand (n=5; 4.6 percent).
- Median PFS follow-up was 8.4 months for Kd-treated patients and
7.6 months for Vd-treated patients. Median PFS was 14.9 months for
Kd-treated patients (95 percent CI: 13.1-17.7) compared to 8.8
months for Vd-treated patients (95 percent CI: 6.6-NE) (HR: 0.57;
95 percent CI: 0.29-1.14), representing a greater than six month
improvement.
- The ORR was 79.6 percent in the Kd arm (95 percent CI:
66.5-89.4) versus 70.9 percent in the Vd arm (95 percent CI:
57.1-82.4) (OR: 1.604; 95 percent CI: 0.664-3.872). The proportion
of patients who achieved a best overall response of a >CR was
higher in the Kd arm (9.3 percent) versus the Vd arm (1.8 percent).
The rate of very good partial response (VGPR) or greater in the Kd
arm (63.0 percent) was more than twice of that in the Vd arm (23.6
percent).
- Similar patient incidence rates of adverse events, grade 3 or
higher adverse events, and grade 3 or higher treatment-related
adverse events were observed between the Kd and Vd arms except for
higher cardiovascular events and hypertension being observed in Kd
arm.
EHA Abstract #P659: Carfilzomib and Dexamethasone Versus
Subcutaneous Bortezomib and Dexamethasone in Patients with Relapsed
or Refractory Multiple Myeloma: Secondary Analysis from the Phase 3
Study ENDEAVOR
This subset analysis assessed the efficacy
and safety of Kd compared to subcutaneous (SC) delivery of Vd,
consistent with current standard of care, and the effect of prior
exposure to bortezomib. The analysis compared Kd patients who had
selected SC bortezomib delivery pre-randomization if randomized to
the Vd arm (n=356) with Vd patients who used SC bortezomib
(n=360).
- Median PFS has not been reached for patients treated with Kd
but was 9.5 months for Vd patients treated with SC bortezomib (HR:
0.58; 95 percent CI: 0.46-0.72). Median overall survival has not
been reached for Kd but was 24.3 months for SC Vd (HR: 0.75; 95
percent CI: 0.53-1.08). ORRs were 76.1 percent for Kd-treated
patients compared to 64.4 percent for SC Vd-treated patients.
- For patients with prior bortezomib exposure, median PFS for Kd
was 13.4 months compared to 8.4 months for SC Vd patients (HR:
0.66; 95 percent CI: 0.50-0.87). ORRs were 70.4 percent for
Kd-treated patients and 62.1 percent for SC Vd-treated
patients.
- Grade 3 or higher adverse events were 74.4 percent in the Kd
arm and 67.5 percent in the SC Vd arm. For patients with prior
bortezomib exposure, grade 3 or higher adverse events were 71.8
percent in the Kd arm compared to 64.5 percent in the SC Vd
arm.
EHA Abstract #P663: Efficacy and Safety by Cytogenetic Risk
Status: Phase 3 Study (ASPIRE) of Carfilzomib, Lenalidomide and
Dexamethasone Versus Lenalidomide and Dexamethasone in Patients
with Relapsed Multiple Myeloma
This pre-planned subgroup
analysis assessed the efficacy and safety of KRd compared with
lenalidomide and dexamethasone (Rd) according to baseline
cytogenetic risk status in patients with relapsed multiple myeloma
who had received one to three prior lines of
therapy.
- For high-risk patients (n=100) treated with KRd, median PFS was
23.1 months (95 percent CI: 12.5-24.2) compared to 13.9 months (95
percent CI: 9.5-16.7) for patients treated with Rd (HR: 0.639; 95
percent CI: 0.369-1.106). ORRs were 79.2 percent for patients
treated with KRd versus 59.6 percent for Rd-treated patients.
- In the standard risk group (n=317), median PFS was 29.6 months
(95 percent CI: 24.1-NE) and 19.5 months (95 percent CI:
14.8-26.0), respectively (HR: 0.657; 95 percent CI: 0.480-0.901).
ORRs for KRd-treated patients were 91.2 percent compared to 73.5
percent for patients treated with Rd.
- Rates of grade 3 or higher adverse events were 89.1 percent for
KRd-treated patients compared to 78.4 percent for Rd-treated
patients in the high-risk group, and 85.6 percent for KRd-treated
patients versus 84.5 percent for Rd-treated patients in the
standard risk group.
About Multiple Myeloma
Multiple myeloma is an
incurable blood cancer, characterized by a recurring pattern of
remission and relapse.1 It is a rare and very
aggressive disease that accounts for approximately one percent of
all cancers.2-4 In Europe, approximately 39,000 patients are
diagnosed with multiple myeloma each year and 24,000 patient deaths
are reported on an annual basis.2 Worldwide, more than
230,000 people are living with multiple myeloma.2
About Amgen's Commitment to Oncology
Amgen Oncology is
committed to helping patients take on some of the toughest cancers,
such as those that have been resistant to drugs, those that
progress rapidly through the body and those where limited treatment
options exist. Amgen's supportive care treatments help patients
combat certain side effects of strong chemotherapy, and our
targeted medicines and immunotherapies focus on more than a dozen
different malignancies, ranging from blood cancers to solid tumors.
With decades of experience providing therapies for cancer patients,
Amgen continues to grow its portfolio of innovative and biosimilar
oncology medicines.
About Kyprolis® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed.5 Kyprolis
has been shown to block proteasomes, leading to an excessive
build-up of proteins within cells.5 In some cells,
Kyprolis can cause cell death, especially in myeloma cells because
they are more likely to contain a higher amount of abnormal
proteins.5,6
Kyprolis is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia and the European Union. Additional
regulatory applications for Kyprolis are underway and have been
submitted to health authorities worldwide.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals is a subsidiary of Amgen and holds development and
commercialization rights to Kyprolis globally, excluding
Japan.
For more information on Kyprolis in the U.S. please visit
www.kyprolis.com.
Important EU Product Safety Information
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.
Kyprolis treatment should be supervised by a physician
experienced in the use of anti-cancer therapy. The most serious
side effects that may occur during Kyprolis treatment include:
Cardiac toxicity, pulmonary toxicities, pulmonary hypertension,
dyspnea, hypertension including hypertensive crises, acute renal
failure, tumor lysis syndrome, infusion reactions,
thrombocytopenia, hepatic toxicity, posterior reversible
encephalopathy syndrome (PRES) and thrombotic thrombocytopenic
purpura/hemolytic uremic syndrome (TTP/HUS). The most common side
effects are anemia, fatigue, diarrhea, thrombocytopenia, nausea,
pyrexia, dyspnea, respiratory tract infection, cough and peripheral
edema.
Please refer to the Summary of Product Characteristics for full
European prescribing information.
Important Safety Information Regarding
Kyprolis® (carfilzomib) for Injection
INDICATION(S)
- KYPROLIS® (carfilzomib) is indicated in
combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS® (carfilzomib) is indicated as a
single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have received one or more lines of
therapy.
IMPORTANT U.S. SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- Patients > 75 years, the risk of cardiac failure
is increased. Patients with New York Heart Association Class III
and IV heart failure, recent myocardial infarction, conduction
abnormalities, angina, or arrhythmias may be at greater risk for
cardiac complications and should have a comprehensive medical
assessment (including blood pressure and fluid management) prior to
starting treatment with KYPROLIS and remain under close
follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event
of drug-induced pulmonary toxicity, discontinue
KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions,
including life-threatening reactions, have occurred in
patients receiving KYPROLIS. Symptoms include fever, chills,
arthralgia, myalgia, facial flushing, facial edema, vomiting,
weakness, shortness of breath, hypotension, syncope, chest
tightness, or angina. These reactions can occur immediately
following or up to 24 hours after administration of KYPROLIS.
Premedicate with dexamethasone to reduce the incidence and severity
of infusion reactions. Inform patients of the risk and of symptoms
of an infusion reaction and to contact a physician immediately if
they occur.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuroradiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full Prescribing Information
at www.kyprolis.com.
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 www.amgen.com and follow us on
www.twitter.com/amgen.
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and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. The discovery of significant problems with a product
similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration or the European Medicines Agency for
the products. The products are not approved for the investigational
use(s) discussed in this news release, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
products for these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
- Jakubowiak A. Management Strategies for Relapsed/Refractory
Multiple Myeloma: Current Clinical Perspectives. Seminars in
Hematology. 2012; 49(3)(1),S16-S32.
- GLOBCAN 2012, Global Prevalence and Incidence. Available
at:
http://globocan.iarc.fr/old/summary_table_pop_prev.asp?selection=224900&title=World&sex=0&window=1&sort=0&submit=%C2%A0Execute%C2%A0.
Accessed on May 6, 2016.
- American Cancer Society. Multiple myeloma. Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf.
Accessed on: May 6, 2016.
- Palumbo A and Anderson K, Multiple myeloma, N Engl J
Med,2011;364:1046–60
- Moreau P, Richardson PG, Cavo M et al. Proteasome Inhibitors in
Multiple Myeloma: 10 Years Later. Blood. 2012;
120(5):947-959.
- Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012;
121(6):893-897.5.
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SOURCE Amgen