THOUSAND OAKS, Calif.,
Sept. 25, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted positive opinions recommending marketing
authorization for:
- Kyprolis® (carfilzomib) in combination with
lenalidomide and dexamethasone for the treatment of adult patients
with multiple myeloma who have received at least one prior
therapy.
- BLINCYTO® (blinatumomab) as a conditional marketing
authorization for the treatment of adults with Philadelphia chromosome-negative
(Ph-) relapsed or refractory B-precursor acute lymphoblastic
leukemia (ALL).
"We are pleased to receive positive CHMP opinions for Kyprolis
and BLINCYTO as this is an important step in providing new
treatment options for patients in Europe with rare forms of cancer," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "For patients
with multiple myeloma, periods of remission become shorter
following each new treatment regimen, underscoring the need
for additional treatment options. The results of the ASPIRE study
demonstrate that Kyprolis extended the time patients live without
their disease progressing. Additionally, there is a critical need
for new therapies for patients with relapsed or refractory B-cell
precursor ALL."
Kyprolis is a proteasome inhibitor for use in the treatment of
patients with relapsed multiple myeloma. Proteasomes play an
important role in cell function and growth by breaking down
proteins that are damaged or no longer needed. Kyprolis blocks
proteasomes, which leads to an excessive build-up of proteins
within cells. 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.
BLINCYTO is the first clinical validation of the bispecific T
cell engager (BiTE®) platform, an innovative approach
that can help the body's own immune system fight cancer.
The CHMP positive opinions will now be reviewed by the European
Commission and if granted, the two products will have marketing
authorization in the 28 member countries of the European Union
(EU), as well as Iceland,
Lichtenstein and Norway.
About Multiple Myeloma
Multiple myeloma is an
incurable blood cancer, characterized by a recurring pattern of
remission and relapse. Multiple myeloma is an orphan disease and
accounts for approximately 1 percent of all
cancers1,2.
About Kyprolis®
(carfilzomib)
Kyprolis was granted orphan drug
designation by the EMA in 2008, and in February 2015, its Marketing Authorization
Application (MAA) was granted accelerated assessment by the EMA.
Kyprolis® (carfilzomib) for Injection was approved
as a monotherapy in the U.S. in July
2012, and in combination with lenalidomide and dexamethasone
in July 2015. Kyprolis is also
approved in Argentina,
Israel, Kuwait, Mexico and Thailand.
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 about Kyprolis, visit www.kyprolis.com.
About Kyprolis European Marketing Authorization
Application
The MAA was based on data from the Phase 3
ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone
versus Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial. The study showed that patients treated with
Kyprolis in combination with lenalidomide and dexamethasone
(regimen referred to as KRd) had increased median time to
progressive disease (PD) or death by 8.7 months compared to
patients treated with lenalidomide and dexamethasone (regimen
referred to as Rd) (26.3 months for KRd compared to 17.6 months for
Rd with HR=0.69; 95 percent CI: 0.57-0.83; 1-sided
p<0.0001). Discontinuation of treatment due to adverse
events (AEs) occurred in 15 percent of patients in the KRd arm
versus 18 percent of patients in the Rd arm.
About ASPIRE
The international, randomized Phase 3
ASPIRE trial evaluated Kyprolis in combination with lenalidomide
and dexamethasone, versus lenalidomide and dexamethasone alone, in
patients with relapsed multiple myeloma following treatment with
one to three prior regimens. The primary endpoint of the trial was
progression-free survival (PFS), defined as the time from
randomization to disease progression or death due to any cause,
whichever is earlier. The study showed that patients treated with
Kyprolis in combination with lenalidomide and low-dose
dexamethasone had increased median time to PD or death by 8.7
months compared to patients treated with lenalidomide and
dexamethasone (26.3 months for KRd compared to 17.6 months for
Rd with HR=0.69; 95 percent CI: 0.57-0.83; 1-sided
p<0.0001). Secondary endpoints included overall
survival (OS), overall response rate (ORR), duration of response
(DOR), disease control rate, health-related quality of life
(HR-QoL) and safety. Patients were randomized to receive Kyprolis
(20 mg/m2 on days 1 and 2 of cycle one only, escalating
to 27 mg/m2 subsequently), in addition to a standard
dosing schedule of lenalidomide (25 mg per day for 21 days on, 7
days off) and dexamethasone (40 mg per week in 4 week cycles),
versus lenalidomide and dexamethasone alone. In the Kyprolis
arm, patients were given a 10 minute infusion on days 1, 2, 8, 9,
15 and 16. Kyprolis was omitted on days 8 and 9 during cycles 13-18
and not administered beyond 18 cycles. The study randomized 792
patients at sites in North
America, Europe and
Israel.
While the data for median OS are not yet mature based on the
prespecified statistical boundary at the interim (1-sided p-value
of smaller than 0.0051), the analysis showed a trend in favor of
KRd compared with Rd (HR=0.79; 95 percent CI: 0.63-0.99; one-sided
p=0.018, two-sided p=0.04). Patients continue to be
monitored for OS. The ORR was 87.1 percent with KRd and 66.7
percent with Rd. Median DOR was 28.6 months for patients receiving
KRd (95 percent CI, 24.9 to 31.3 months) and 21.2 months for
patients receiving Rd (95 percent CI, 16.7 to 25.8 months). In the
KRd and Rd groups, 32 percent versus 9 percent of patients achieved
a complete response or higher (stringent complete response [sCR] or
complete response [CR]), a measurement indicating depth of
response.
The rate of deaths due to AEs within 30 days of the last dose
was balanced between the KRd arm and the Rd arm. The most common
causes of death not due to PD occurring in patients in the KRd arm
compared to the Rd arm included cardiac disorders (3 percent versus
2 percent), infection (2 percent versus 3 percent), renal (0
percent versus less than 1 percent) and other AEs (2 percent
versus 3 percent). Serious AEs were reported in 60 percent of the
patients in the KRd arm and 54 percent of the patients in the Rd
arm. The most common serious AEs reported in the KRd arm compared
to the Rd arm were pneumonia (14 percent versus 11 percent),
respiratory tract infection (4 percent versus 2 percent), pyrexia
(4 percent versus 2 percent) and pulmonary embolism (3 percent
versus 2 percent). Discontinuation of treatment due to AEs
occurred in 15 percent of patients in the KRd arm versus 18 percent
of patients in the Rd arm. AEs leading to
discontinuation of Kyprolis occurred in 12 percent of patients and
the most common events included pneumonia (1 percent), myocardial
infarction (1 percent) and upper respiratory tract infection (1
percent).
The ASPIRE data were presented at the 56th Annual
Meeting of the American Society of Hematology and published in
The New England Journal of Medicine in December
2014.3
About Acute Lymphoblastic Leukemia (ALL)
It is
estimated that there are close to 600 adults with Ph- relapsed or
refractory B-precursor ALL in France, Germany, Italy, Spain,
and the U.K.4
About BLINCYTO® (blinatumomab)
BLINCYTO 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.
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.
BLINCYTO was granted breakthrough therapy and priority review
designations by the U.S. Food and Drug Administration, and is now
approved in the U.S. for the treatment of Ph- relapsed or
refractory B-cell precursor ALL. This indication is approved under
accelerated approval. Continued approval for this indication may be
contingent upon verification of clinical benefit in subsequent
trials.
About BLINCYTO European Conditional Marketing Authorization
Application
The CHMP recommended granting BLINCYTO a
conditional marketing authorization for the treatment of adults
with Ph- relapsed or refractory B-precursor ALL.
Conditional license requires the license to be renewed every
year and it will be converted to full standard license once
post-licensing commitments have been fulfilled. Amgen expects a
decision on the conditional MAA from the European Commission
in the coming months.
The BLINCYTO conditional marketing authorization application is
based on results of the '211 and '206 trials. In the '211
study:
- 42.9 percent of evaluable patients receiving BLINCYTO achieved
complete remission or complete remission with partial hematological
recovery (CR/CRh*).
- 17 percent of patients underwent allogeneic hematopoietic
stem cell transplantation (HSCT) in CR/CRh* induced with
BLINCYTO
- 82.2 percent of those who achieved CR/CRh* achieved deep
molecular remission, or minimal residual disease (MRD) response, a
measure of eradication of residual disease at the molecular
level.
- The most serious adverse reactions included: infections (31.7
percent), neurologic events (16.4 percent), neutropenia/febrile
neutropenia (15.3 percent), cytokine release syndrome (0.5 percent)
and tumor lysis syndrome (0.5 percent).
About Study '211
Study '211 evaluated blinatumomab in an open-label, multicenter,
single-arm Phase 2 study. Eligible patients were at least 18 years
of age with Ph- relapsed or refractory B-precursor ALL. Relapsed or
refractory was defined as relapsed with a first remission duration
of less than or equal to 12 months in first salvage, or relapsed or
refractory after the first salvage, or relapsed within 12 months of
allogeneic hematopoietic stem cell transplantation (HSCT), and
greater than or equal to 10 percent blasts in bone marrow. The
primary endpoint was the CR/CRh* rate within two cycles of
blinatumomab. Of the 189 patients evaluated in the trial, 42.9
percent (81/189; 95 percent CI, 35.7 – 50.2) achieved CR or CRh*
within two cycles of treatment with blinatumomab with the majority
of responses (79 percent [64/81]) occurring within the first cycle
of treatment. In a prespecified exploratory analysis, 82.2 percent
(60/73) of MRD evaluable patients with CR/CRh* also had a MRD
response. The most common adverse reactions (greater than 20
percent) were infusion-related reactions (67.2 percent), infections
(63 percent), pyrexia (59.8 percent), headache (34.4 percent),
febrile neutropenia (28 percent), peripheral edema (25.9 percent),
nausea (24.3 percent), hypokalemia (23.8 percent), constipation
(20.6 percent) and anemia (20.1 percent). The most serious adverse
reactions that occurred during blinatumomab treatment included:
infections (31.7 percent), neurologic events (16.4 percent),
neutropenia/febrile neutropenia (15.3 percent), cytokine release
syndrome (0.5 percent) and tumor lysis syndrome (0.5 percent).
About Study '206
Study '206 evaluated the safety and
efficacy of blinatumomab in an open-label, multicenter,
dose-escalation Phase 2 study of 36 patients, who were at least 18
years of age with B-precursor ALL relapsed after at least induction
and consolidation or having refractory disease with greater than 5
percent blasts in bone marrow, had an Eastern Cooperative Oncology
Group (ECOG) performance status of at most 2, had a life expectancy
of at least 12 weeks, and who did not have autologous HSCT within
six weeks prior to start of treatment, allogeneic HSCT within three
months prior to start of treatment, or previous treatment with
blinatumomab.
The CR/CRh* rate was 69.4 percent (25/36) with 15 patients
achieving CR (41.7 percent; 95 percent CI, 25.5 percent - 59.2
percent), and 10 patients achieving CRh* (27.8 percent; 95 percent
CI, 14.2 percent - 45.2 percent). Of the patients with hematologic
CR, 88 percent (22/25) also had MRD responses. The median duration
of remission was 8.9 months, and the median relapse-free survival
(RFS) was 7.6 months. The median OS was 9.8 months. Overall safety
results from this study were consistent with the known blinatumomab
safety profile.
Kyprolis U.S. Product Safety Information
Important Safety Information Regarding Kyprolis (carfilzomib)
for Injection U.S. Indication
This safety information is
specific to the current U.S. approved indication
Cardiac Toxicities
New onset or worsening of
pre-existing cardiac failure (e.g., congestive heart failure,
pulmonary edema, and decreased ejection fraction), restrictive
cardiomyopathy, myocardial ischemia, and myocardial infarction
including fatalities have occurred following administration of
Kyprolis. Death due to cardiac arrest has occurred within a day of
Kyprolis administration.
Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until
recovery, and consider whether to restart Kyprolis based on a
benefit/risk assessment.
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, and conduction abnormalities may be at greater risk for
cardiac complications.
Acute Renal Failure
Cases of acute renal failure and
renal insufficiency adverse events (renal impairment, acute renal
failure, and 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. This risk was greater in patients
with a baseline reduced estimated creatinine clearance. 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 and
should be based on an assessment of the patient's underlying risks,
treatment regimen, and clinical status.
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. Reduce or withhold dose as
appropriate.
Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic
Syndrome (TTP/HUS)
Cases of 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 neuro-radiological 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 and the
potential hazard to the fetus if Kyprolis is used during
pregnancy.
ADVERSE REACTIONS
The most common adverse events
occurring in at least 20% of patients treated with Kyprolis in
monotherapy trials: anemia, fatigue, thrombocytopenia, nausea,
pyrexia, decreased platelets, dyspnea, diarrhea, decreased
lymphocyte, headache, decreased hemoglobin, cough, edema
peripheral.
The most common adverse events occurring in at least 20% of
patients treated with Kyprolis in the combination therapy trial:
decreased lymphocytes, decreased absolute neutrophil count,
decreased phosphorus, anemia, neutropenia, decreased total white
blood cell count, decreased platelets, diarrhea, fatigue,
thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory
tract infection, decreased hemoglobin, hypokalemia.
Full U.S. prescribing information is available at
www.kyprolis.com.
BLINCYTO U.S. Product Safety Information
Important
Safety Information Regarding BLINCYTO® (blinatumomab)
U.S. Indication
This safety information is specific to the
current U.S. approved indication.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
Contraindications
BLINCYTO® is
contraindicated in patients with a known hypersensitivity to
blinatumomab or to any component of the product formulation.
Warnings and Precautions
Cytokine Release Syndrome (CRS): Life-threatening or fatal
CRS occurred in patients receiving BLINCYTO®. Infusion
reactions have occurred and may be clinically indistinguishable
from manifestations of CRS. Closely monitor patients for signs and
symptoms of serious events such as pyrexia, headache, nausea,
asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total
bilirubin (TBILI), disseminated intravascular coagulation (DIC),
capillary leak syndrome (CLS), and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Interrupt or discontinue BLINCYTO® as outlined in the
Prescribing Information (PI).
Neurological Toxicities: Approximately 50% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. Severe, life-threatening, or fatal
neurological toxicities occurred in approximately 15% of patients,
including encephalopathy, convulsions, speech disorders,
disturbances in consciousness, confusion and disorientation, and
coordination and balance disorders. The median time to onset of any
neurological toxicity was 7 days. Monitor patients for signs or
symptoms and interrupt or discontinue BLINCYTO® as
outlined in the PI.
Infections: Approximately 25% of patients receiving
BLINCYTO® experienced serious infections, some of which
were life-threatening or fatal. Administer prophylactic antibiotics
and employ surveillance testing as appropriate during treatment.
Monitor patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO® as needed.
Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS
has been observed. Preventive measures, including pretreatment
nontoxic cytoreduction and on treatment hydration, should be used
during BLINCYTO® treatment. Monitor patients for signs
and symptoms of TLS and interrupt or discontinue
BLINCYTO® as needed to manage these events.
Neutropenia and Febrile Neutropenia, including
life-threatening cases, have been observed. Monitor appropriate
laboratory parameters during BLINCYTO® infusion and
interrupt BLINCYTO® if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO® are at risk for loss of
consciousness, and should be advised against driving and engaging
in hazardous occupations or activities such as operating heavy or
potentially dangerous machinery while BLINCYTO® is being
administered.
Elevated Liver Enzymes: Transient elevations in liver
enzymes have been associated with BLINCYTO® treatment.
The majority of these events were observed in the setting of CRS.
The median time to onset was 15 days. Grade 3 or greater elevations
in liver enzymes occurred in 6% of patients outside the setting of
CRS and resulted in treatment discontinuation in less than 1% of
patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and
TBILI prior to the start of and during BLINCYTO®
treatment. BLINCYTO® treatment should be interrupted if
transaminases rise to > 5 times the upper limit of normal (ULN)
or if TBILI rises to > 3 times ULN.
Leukoencephalopathy: Although the clinical significance
is unknown, cranial magnetic resonance imaging (MRI) changes
showing leukoencephalopathy have been observed in patients
receiving BLINCYTO®, especially in patients previously
treated with cranial irradiation and anti-leukemic chemotherapy.
Preparation and administration errors have occurred with
BLINCYTO® treatment. Follow instructions for preparation
(including admixing) and administration in the PI strictly to
minimize medication errors (including underdose and overdose).
Adverse Reactions
The most commonly reported adverse
reactions (≥ 20%) in clinical trials were pyrexia (62%), headache
(36%), peripheral edema (25%), febrile neutropenia (25%), nausea
(25%), hypokalemia (23%), rash (21%), tremor (20%), diarrhea (20%)
and constipation (20%). Serious adverse reactions were reported in
65% of patients. The most common serious adverse reactions (≥ 2%)
included febrile neutropenia, pyrexia, pneumonia, sepsis,
neutropenia, device-related infection, tremor, encephalopathy,
infection, overdose, confusion, Staphylococcal bacteremia, and
headache.
U.S. Dosage and Administration Guidelines
BLINCYTO® is administered as a continuous intravenous
infusion at a constant flow rate using an infusion pump which
should be programmable, lockable, non-elastomeric, and have an
alarm. It is very important that the instructions for
preparation (including admixing) and administration provided in the
full Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose). Please
see full U.S. Prescribing Information and medication guide for
BLINCYTO at www.BLINCYTO.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 biologics manufacturing 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
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business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our ongoing
restructuring plan. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or
their ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our product candidates is limited to the European Union.
Such product candidates are not approved by the European Medicines
Agency, and no conclusions can or should be drawn regarding the
safety or effectiveness of the product candidates.
CONTACT:
Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(Investors)
Amgen, Europe
Emma Gilbert, +41 41 369 2542
References:
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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 March 9, 2015
- Palumbo A and Anderson K, Multiple myeloma, N Engl J Med,
2011;364:1046–60
- Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib,
Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma. N
Engl J Med. 2015; 372:142-152.
- Katz AJ, et al. Acute lymphoblastic leukemia: an assessment of
international incidence, survival, and disease burden. Cancer
Causes Control. 2015;1-16. Retrieved from:
http://link.springer.com/article/10.1007%2Fs10552-015-0657-6.
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SOURCE Amgen