Multiple Investigator Sponsored Studies
Support the Potential of
BLINCYTO® (blinatumomab) Across Acute
Lymphoblastic Leukemia Treatment Paradigm
New Data Reinforce KYPROLIS®
(carfilzomib) as an Important Treatment Option for Relapsed or
Refractory Multiple Myeloma
Additional Analyses Support Eculizumab (a
biosimilar candidate to SOLIRIS®) as a Potential Option
in Paroxysmal Nocturnal Hemoglobinuria
THOUSAND
OAKS, Calif., Dec. 8, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the
presentation of new data from its blood cancer portfolio and
pipeline at the 65th American Society of Hematology
(ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San
Diego.
"Data at this year's ASH meeting illustrate the expanding
potential of our innovative hematology medicines, BLINCYTO and
KYPROLIS, as well as our commitment to providing additional
treatment options with our biosimilar eculizumab," said
David M. Reese, M.D., executive vice president of Research and
Development at Amgen. "As the pioneer of T-cell engager
technology and building on nearly a decade of real-world
experience, we continue to advance our first-in-class
BiTE® molecule, BLINCYTO, into earlier lines of
treatment where we have seen encouraging data in patients living
with acute lymphoblastic leukemia."
Abstracts are available on the ASH website.
Key Abstracts and Presentation Times:
Amgen Sponsored Abstracts
KYPROLIS® (carfilzomib)
- Real-World Outcomes for Relapsed or Refractory Multiple
Myeloma Patients Treated with Lenalidomide and Daratumumab Sparing
Triplet Regimens: A United States Retrospective Cohort
Study
Abstract #4705, Session #652, Monday, December 11 from 6:00 - 8:00 p.m. PT
Eculizumab (investigational biosimilar ABP 959
candidate to SOLIRIS®)
- Efficacy of Parallel and Crossover Analysis As Well As
Pharmacokinetic Similarity Were Confirmed between ABP 959 and
Eculizumab Reference Product in Patients with PNH
Abstract
#4092, Session #508, Monday, December
11 from 6:00 - 8:00 p.m.
PT
Investigator Sponsored Studies
BLINCYTO® (blinatumomab)
- Chemotherapy-Free Combination of Blinatumomab and Ponatinib
in Adults With Newly Diagnosed Philadelphia Chromosome–Positive
Acute Lymphoblastic Leukemia: Updates From a Phase II
Trial
Abstract #2827, Session #612, Sunday, December 10 from 6:00 - 8:00 p.m. PT
- Phase II Study of Low-Intensity Chemotherapy
(Mini-Hyper-CVD) and Ponatinib Followed by Blinatumomab and
Ponatinib in Patients With Philadelphia Chromosome-Positive Acute
Lymphoblastic Leukemia
Abstract #2868, Session #614,
Sunday, December 10 from 6:00 - 8:00
p.m. PT
- Assessment of Outcomes of Consolidation Therapy By Number of
Cycles of Blinatumomab Received in Newly Diagnosed Measurable
Residual Disease Negative Patients with B-Lineage Acute
Lymphoblastic Leukemia: In the ECOG-ACRIN E1910 Randomized Phase
III National Clinical Trials Network Trial*
Abstract #2877,
Session #614, Sunday, December 10
from 6:00 - 8:00 p.m. PT
- Phase 2 Trial of Mini-Hyper-CVD Plus Inotuzumab Ozogamicin,
With or Without Blinatumomab, in Older Patients With Newly
Diagnosed Philadelphia Chromosome-Negative B-Cell Acute
Lymphoblastic Leukemia
Abstract #2878, Session #614,
Sunday, December 10 from 6:00 - 8:00
p.m. PT
- Pediatric Patients with High-Risk B-Cell ALL in First
Complete Remission May Benefit from Less Toxic Immunotherapy with
Blinatumomab – Results from Randomized Controlled Phase 3 Trial
AIEOP-BFM ALL 2017
Abstract #825, Session #614, Monday, December 11 from 2:45 - 4:15 p.m. PT
- Dose Reduced Chemotherapy in Sequence with Blinatumomab for
Newly Diagnosed Older Patients with Ph/BCR::ABL Negative
B-Precursor Adult Lymphoblastic Leukemia (ALL): Preliminary Results
of the GMALL Bold Trial
Abstract #964, Session #614,
Monday, December 11 from 4:30 - 6:00
p.m. PT
- Updated Results from a Phase II Study of Hyper-CVAD, with or
without Inotuzumab Ozogamicin, and Sequential Blinatumomab in
Patients with Newly Diagnosed B-cell Acute Lymphoblastic
Leukemia
Abstract #4245, Session #614, Monday, December 11 from 6:00 - 8:00 p.m.
PT
- Comparison between Dasatinib-Blinatumomab Vs
Ponatinib-Blinatumomab Chemo-Free Strategy for Newly Diagnosed Ph+
Acute Lymphoblastic Leukemia Patients. Preliminary Results of the
Gimema ALLL2820 Trial
Abstract #4249, Session #614,
Monday, December 11 from 6:00 - 8:00
p.m. PT
*E1910 is sponsored by National Cancer
Institute (NCI), part of the National Institutes of Health, and
conducted by the NCI Funded National Clinical Trial
Network.
KYPROLIS® (carfilzomib)
- Carfilzomib-Lenalidomide-Dexamethasone (KRd) Vs.
Lenalidomide-Dexamethasone (Rd) in Newly Diagnosed Fit or
Intermediate-Fit Multiple Myeloma Patients Not Eligible for
Autologous Stem-Cell Transplantation (Phase III EMN20 Trial):
Analysis of Sustained Undetectable Minimal Residual Disease
(MRD)
Abstract #205, Session #653, Saturday, December 9 from 2:00 - 3:30 p.m. PT
- Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone
Induction and Consolidation with Tandem Transplant in High-Risk
Newly Diagnosed Myeloma Patients: Final Results of the Phase 2
Study IFM 2018-04
Abstract #207, Session #653, Saturday, December 9 from 2:00 - 3:30 p.m. PT
- GEM2017FIT Trial: Induction Therapy with
Bortezomib-Melphalan and Prednisone (VMP) Followed By Lenalidomide
and Dexamethasone (Rd) Versus Carfilzomib, Lenalidomide and
Dexamethasone (KRd) Plus/Minus Daratumumab (D), 18 Cycles, Followed
By Consolidation and Maintenance Therapy with Lenalidomide and
Daratumumab: Phase III, Multicenter, Randomized Trial for Elderly
Fit Newly Diagnosed Multiple Myeloma (NDMM) Patients Aged between
65 and 80 Years
Abstract #209, Session #653, Saturday, December 9 from 2:00 - 3:30 p.m. PT
- Results of the Phase III Randomized Iskia Trial:
Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone Vs
Carfilzomib-Lenalidomide-Dexamethasone As Pre-Transplant Induction
and Post-Transplant Consolidation in Newly Diagnosed Multiple
Myeloma Patients
Abstract #4, Plenary Scientific
Session, Sunday, December 10 from 2:00
- 4:00 p.m. PT
About BLINCYTO® (blinatumomab)
BLINCYTO is
a BiTE® (bispecific T-cell engager) immuno-oncology
therapy that targets CD19 surface antigens on B cells. BiTE
molecules fight cancer by helping the body's immune system detect
and target malignant cells by engaging T cells (a type of white
blood cell capable of killing other cells perceived as threats) to
cancer cells. By bringing T cells near cancer cells, the T cells
can inject toxins and trigger cancer cell death (apoptosis). BiTE
immuno-oncology therapies 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 approved in the U.S. for the
treatment of:
- CD19-positive B-cell precursor ALL in first or second complete
remission with minimal residual disease (MRD) greater than or equal
to 0.1% in adults and pediatric patients.
- relapsed or refractory CD19-positive B-cell precursor ALL in
adults and pediatric patients.
In the European Union (EU), BLINCYTO is indicated as monotherapy
for the treatment of:
- adults with Philadelphia
chromosome-negative CD19 positive relapsed or refractory
B-precursor acute lymphoblastic leukemia (ALL). Patients with
Philadelphia chromosome-positive
B-precursor ALL should have failed treatment with at least 2
tyrosine kinase inhibitors (TKIs) and have no alternative treatment
options.
- adults with Philadelphia
chromosome-negative CD19 positive B-precursor ALL in first or
second complete remission with minimal residual disease (MRD)
greater than or equal to 0.1%.
- pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19 positive
B-precursor ALL which is refractory or in relapse after receiving
at least two prior therapies or in relapse after receiving prior
allogeneic hematopoietic stem cell transplantation.
- pediatric patients aged 1 year or older with high-risk first
relapsed Philadelphia
chromosome-negative CD19 positive B-precursor ALL as part of the
consolidation therapy.
BLINCYTO® IMPORTANT SAFETY INFORMATION
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® and treat with corticosteroids 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): CRS, which may be
life-threatening or fatal, occurred in 15% of patients with R/R ALL
and in 7% of patients with MRD-positive ALL. The median time to
onset of CRS is 2 days after the start of infusion and the median
time to resolution of CRS was 5 days among cases that resolved.
Closely monitor and advise patients to contact their healthcare
professional for signs and symptoms of serious adverse events such
as fever, headache, nausea, asthenia, hypotension, increased
alanine aminotransferase (ALT), increased aspartate
aminotransferase (AST), increased total bilirubin (TBILI), and
disseminated intravascular coagulation (DIC). The manifestations of
CRS after treatment with BLINCYTO® overlap with those of
infusion reactions, capillary leak syndrome, and hemophagocytic
histiocytosis/macrophage activation syndrome. If severe CRS occurs,
interrupt BLINCYTO® until CRS resolves. Discontinue
BLINCYTO® permanently if life-threatening CRS occurs.
Administer corticosteroids for severe or life-threatening CRS.
- Neurological Toxicities: Approximately 65% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. The median time to the first event was
within the first 2 weeks of BLINCYTO® treatment and the
majority of events resolved. The most common (≥ 10%) manifestations
of neurological toxicity were headache and tremor. Severe,
life–threatening, or fatal neurological toxicities occurred in
approximately 13% of patients, including encephalopathy,
convulsions, speech disorders, disturbances in consciousness,
confusion and disorientation, and coordination and balance
disorders. Manifestations of neurological toxicity included cranial
nerve disorders. Monitor patients for signs or symptoms and
interrupt or discontinue BLINCYTO® as outlined in the
PI.
- Infections: Approximately 25% of patients receiving
BLINCYTO® in clinical trials experienced serious
infections such as sepsis, pneumonia, bacteremia, opportunistic
infections, and catheter-site 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), which may be life-threatening or
fatal, 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 (including, but not limited to, white blood cell count
and absolute neutrophil count) 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 with a
median time to onset of 3 days. In patients receiving
BLINCYTO®, although the majority of these events were
observed in the setting of CRS, some cases of elevated liver
enzymes were observed outside the setting of CRS, with a median
time to onset of 19 days. Grade 3 or greater elevations in liver
enzymes occurred in approximately 7% of patients outside the
setting of CRS and resulted in treatment discontinuation in less
than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase,
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.
- Pancreatitis: Fatal pancreatitis has been reported in patients
receiving BLINCYTO® in combination with dexamethasone in
clinical trials and the post-marketing setting. Evaluate patients
who develop signs and symptoms of pancreatitis and interrupt or
discontinue BLINCYTO® and dexamethasone as needed.
- 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 antileukemic 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).
- Immunization: Vaccination with live virus vaccines is not
recommended for at least 2 weeks prior to the start of
BLINCYTO® treatment, during treatment, and until immune
recovery following last cycle of BLINCYTO®.
- Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions,
including fatal reactions and the "gasping syndrome", have been
reported in very low birth weight (VLBW) neonates born weighing
less than 1500 g, and early preterm neonates (infants born less
than 34 weeks gestational age) who received intravenous drugs
containing benzyl alcohol as a preservative. Early preterm VLBW
neonates may be more likely to develop these reactions, because
they may be less able to metabolize benzyl alcohol.
Use the preservative-free preparations of
BLINCYTO® where possible in neonates. When
prescribing BLINCYTO® (with preservative) for
neonatal patients, consider the combined daily metabolic load of
benzyl alcohol from all sources including
BLINCYTO® (with preservative), other products
containing benzyl alcohol or other excipients (e.g., ethanol,
propylene glycol) which compete with benzyl alcohol for the same
metabolic pathway.
Monitor neonatal patients receiving BLINCYTO® (with
preservative) for new or worsening metabolic acidosis. The minimum
amount of benzyl alcohol at which serious adverse reactions
may occur in neonates is not known. The
BLINCYTO® 7-Day bag (with preservative) contains
7.4 mg of benzyl alcohol per mL.
- Embryo-Fetal Toxicity: Based on its mechanism of action,
BLINCYTO® may cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential risk to
the fetus. Advise females of reproductive potential to use
effective contraception during treatment
with BLINCYTO® and for 48 hours after the last
dose.
Adverse Reactions
- The most common adverse reactions (≥ 20%) are pyrexia,
infusion-related reactions, infections (pathogen unspecified),
headache, neutropenia, anemia, and thrombocytopenia.
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).
INDICATIONS
- BLINCYTO® (blinatumomab) is indicated for the
treatment of CD19-positive B-cell precursor acute lymphoblastic
leukemia (ALL) in first or second complete remission with minimal
residual disease (MRD) greater than or equal to 0.1% in adult and
pediatric patients.
- BLINCYTO® is indicated for the treatment of relapsed
or refractory CD19-positive B-cell precursor acute lymphoblastic
leukemia (ALL) in adult and pediatric patients.
Please see
BLINCYTO® full Prescribing
Information, including BOXED WARNINGS.
About BiTE®
Technology
BiTE® (bispecific T-cell engager)
technology is a targeted immuno-oncology platform that is designed
to engage patient's own T cells to any tumor-specific antigen,
activating the cytotoxic potential of T cells to eliminate
detectable cancer. The BiTE immuno-oncology platform has the
potential to treat different tumor types through tumor-specific
antigens. The BiTE platform has a goal of leading to off-the-shelf
solutions, which have the potential to make innovative T cell
treatment available to all providers when their patients need
it. Amgen is advancing more than a dozen BiTE molecules
across a broad range of hematologic malignancies and solid tumors,
further investigating BiTE technology with the goal of enhancing
patient experience and therapeutic potential. To learn more about
BiTE technology, visit
https://www.amgenoncology.com/bite-platform.html.
About KYPROLIS® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed.1 KYPROLIS
has been shown to block proteasomes, leading to an excessive
build-up of proteins within cells.2 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.1,2
Since its first approval in 2012, more than 285,000 patients
worldwide have received KYPROLIS. KYPROLIS is approved in
the U.S. for the following:
- for the treatment of adult patients with relapsed or refractory
multiple myeloma who have received one to three lines of therapy in
combination with
- Lenalidomide and dexamethasone; or
- Dexamethasone; or
- Daratumumab and dexamethasone.
- Daratumumab and hyaluronidase-fihj and dexamethasone; or
- Isatuximab and dexamethasone
- 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 Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New
Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi
Arabia, Serbia, Singapore,
S. Africa, S. Korea, Switzerland,
Taiwan, Thailand, Turkey and United
Arab Emirates.
KYPROLIS® IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), 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 administration.
- Monitor patients for signs or symptoms of cardiac failure or
ischemia. Evaluate promptly if cardiac toxicity is suspected.
Withhold KYPROLIS® for Grade 3 or 4 cardiac adverse
reactions until recovery, and consider whether to restart 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.
- For 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 prior to starting treatment with KYPROLIS®
and remain under close follow-up with fluid management.
Acute Renal Failure
- Cases of acute renal failure, including some fatal renal
failure events, and renal insufficiency (including renal failure)
have occurred. 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. Patients with 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, and withhold until 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. Some
events have been fatal. In the event of drug-induced pulmonary
toxicity, discontinue KYPROLIS®.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported. 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 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 based on a
benefit/risk assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed, some fatal. Control hypertension
prior to starting KYPROLIS®. Monitor blood pressure
regularly in all patients. If hypertension cannot be adequately
controlled, withhold KYPROLIS® and evaluate.
Consider whether to restart based on a benefit/risk
assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed. Provide
thromboprophylaxis for patients being treated with the combination
of KYPROLIS® with dexamethasone or with lenalidomide
plus dexamethasone or with daratumumab and dexamethasone. The
thromboprophylaxis regimen should be based on an assessment of the
patient's underlying risks.
- For patients using hormonal contraception associated with a
risk of thrombosis, consider an alternative method of effective
contraception during treatment.
Infusion-Related Reactions
- Infusion-related reactions, including life-threatening
reactions, have occurred. Signs and symptoms include fever,
chills, arthralgia, myalgia, facial flushing, facial edema,
laryngeal 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. Premedicate with dexamethasone to reduce the
incidence and severity of infusion-related reactions.
Hemorrhage
- Fatal or serious cases of hemorrhage have been
reported. Hemorrhagic events have included gastrointestinal,
pulmonary, and intracranial hemorrhage and epistaxis. Promptly
evaluate signs and symptoms of blood loss. Reduce or withhold dose
as appropriate.
Thrombocytopenia
- KYPROLIS® causes thrombocytopenia with recovery
to baseline platelet count usually by the start of the next cycle.
Monitor platelet counts frequently during treatment. Reduce or
withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have occurred.
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. Monitor for signs and
symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the
diagnosis of TTP/HUS is excluded, KYPROLIS® may be
restarted. The safety of reinitiating KYPROLIS® is
not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving
KYPROLIS®. If PRES is suspected, discontinue and
evaluate with appropriate imaging. The safety of reinitiating
KYPROLIS® is not known.
Progressive Multifocal Leukoencephalopathy (PML)
- Cases of PML, including fatal cases, have occurred. In
addition to KYPROLIS®, other contributary factors may
include prior or concurrent use of immunosuppressive therapy.
Consider PML in any patient with new onset of or changes in
pre-existing neurological signs or symptoms. If PML is suspected,
discontinue and initiate evaluation for PML including neurology
consultation.
Increased Fatal and Serious Toxicities in Combination with
Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible
Patients
- In a clinical trial of transplant-ineligible patients with
newly diagnosed multiple myeloma comparing
KYPROLIS®, melphalan, and prednisone (KMP) vs
bortezomib, melphalan, and prednisone (VMP), a higher incidence of
serious and fatal adverse reactions was observed in patients in the
KMP arm. KMP is not indicated for transplant-ineligible patients
with newly diagnosed multiple myeloma.
Embryo-fetal Toxicity
- KYPROLIS® can cause fetal harm when administered to
a pregnant woman.
- Advise pregnant women of the potential risk to a fetus. Females
of reproductive potential should use effective contraception during
treatment with KYPROLIS® and for 6 months following the
final dose. Males of reproductive potential should use effective
contraception during treatment with KYPROLIS® and for 3
months following the final dose.
Adverse Reactions
- The most common adverse reactions in the combination therapy
trials: anemia, diarrhea, fatigue, hypertension, pyrexia, upper
respiratory tract infection, thrombocytopenia, cough, dyspnea, and
insomnia.
- The most common adverse reactions in monotherapy trials:
anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea,
diarrhea, headache, cough, edema peripheral.
Please see accompanying full Prescribing Information.
INDICATIONS
- KYPROLIS® (carfilzomib) is indicated in combination
with dexamethasone, or with lenalidomide plus dexamethasone, or
with daratumumab plus dexamethasone, or with daratumumab plus
hyaluronidase-fihj plus dexamethasone, or with isatuximab plus
dexamethasone for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS® 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.
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.
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identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products, including our devices, after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
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. 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, including in Puerto Rico, 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. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. 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. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. 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 collaborate
with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. There can be no
guarantee that we will be able to realize any of the strategic
benefits, synergies or opportunities arising from the Horizon
acquisition, and such benefits, synergies or opportunities may take
longer to realize than expected. We may not be able to
successfully integrate Horizon, and such acquisition or integration
may take longer, be more difficult or cost more than expected. A
breakdown, cyberattack or information security breach of our
information technology systems could compromise the
confidentiality, integrity and availability of our systems and our
data. Our stock price is volatile and may be affected by a number
of events. Our business and operations may be negatively affected
by the failure, or perceived failure, of achieving our
environmental, social and governance objectives. The effects of
global climate change and related natural disasters could
negatively affect our business and operations. Global economic
conditions may magnify certain risks that affect our business. 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. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates. Further, any
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 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
Elissa Snook, 609-251-1407
(media)
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
1 Moreau P, et al. Blood.
2012;120(5):947-59.
2 Kortuem KM and Stewart AK. Blood.
2013;7;121(6):893.
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SOURCE Amgen