Amgen To Present New Data Showcasing Extensive Portfolio And Exciting Early Oncology Pipeline At ASH 2018
THOUSAND OAKS, Calif., Nov. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new clinical data will be presented at the 60(th) American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, Dec. 1-4, 2018. Data across an array of malignancies will be featured in 45 abstracts, including nine oral presentations, from the Company's broad portfolio and early-stage pipeline.
The breadth of data to be presented at ASH this year represent Amgen's continued search for answers to complex scientific questions, leveraging its long-standing expertise in blood cancers to develop early immuno-oncology pipeline candidates and innovative biologics in areas of significant unmet need. Notable data include two oral presentations on first-in-human studies evaluating two early-stage bi-specific T cell engager (BiTE(®)) molecules - AMG 420 and AMG 330. BiTE(®) molecules are designed to harness the immune system and can be modified in an effort to enable cytotoxic T cells in the body to recognize cancer cells and destroy them. Additional data from Amgen's hematology franchise will also be featured, including long-term overall survival (OS) data for BLINCYTO(®) (blinatumomab) in patients who had achieved complete minimal residual disease (MRD) response and for once-weekly dosing of KYPROLIS(®) (carfilzomib) in combination with dexamethasone.
"For nearly four decades, Amgen has been at the forefront of cutting-edge science that has helped change treatment paradigms for patients with difficult-to-treat blood cancers. Today, we are on the cusp of a new wave of advances that harness the body's own immune system to transform cancer care," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We're excited to present the first data from our early oncology pipeline, including two investigational BiTE(®) candidates, which demonstrate our commitment to tackling the toughest scientific questions for cancer patients."
A complete listing of abstracts can be found on the ASH website. Notable abstracts of interest include:
Expanding Investigation of BiTE(®) Across Hematologic Malignancies
-- A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 Bispecific
T-Cell Engager (BiTE(®)) Antibody Construct, in Relapsed/Refractory
Acute Myeloid Leukemia (R/R AML)Abstract #25, Oral Presentation,
Saturday, Dec. 1 at 7:30 a.m. PT in Manchester Grand Hyatt San Diego,
Seaport Ballroom F
-- Open-Label, Phase 2 Study of Blinatumomab as Second Salvage Therapy in
Adults with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Abstract #400, Oral Presentation, Sunday, Dec. 2 at 12:45 p.m. PT in
Marriott Marquis San Diego Marina, Pacific Ballroom 20
-- Treatment with AMG 420, an anti-B-Cell Maturation Antigen (BCMA)
Bispecific T-cell Engager (BiTE(®)) Antibody Construct, Induces Minimal
Residual Disease (MRD) Negative Complete Responses in Relapsed and/or
Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a
First-in-Human (FIH) Phase I Dose Escalation StudyAbstract #1010, Oral
Presentation, Monday, Dec. 3 at 6:30 p.m. PT in San Diego Convention
Center, Ballroom 20D
-- Blinatumomab for Minimal Residual Disease (MRD) in Adults with B-Cell
Precursor Acute Lymphoblastic Leukemia (BCP-ALL): Median Overall
Survival (OS) Is Not Reached in Complete MRD Responders at a Median
Follow-up of 53.1 MonthsAbstract #554, Oral Presentation, Monday, Dec. 3
at 7:15 a.m. PT in San Diego Convention Center, Ballroom 20A
Evaluating Outcomes in Multiple Myeloma
-- Carfilzomib in Relapsed or Refractory Multiple Myeloma Patients with
Early or Late Relapse Following Prior Therapy: An Analysis of Overall
Survival in Subgroups from the Randomized Phase 3 ASPIRE and ENDEAVOR
TrialsAbstract #1964, Poster Presentation, Saturday Dec. 1 at 6:15 p.m.
PT in San Diego Convention Center, Hall GH
-- Efficacy and Safety of Once-weekly vs Twice-weekly Carfilzomib Plus
Dexamethasone: Subgroup Analysis of the Phase 3 A.R.R.O.W. Study
(NCT02412878) by Prior LinesAbstract #3244, Poster Presentation, Sunday,
Dec. 2 from 6 p.m. PT in San Diego Convention Center, Hall GH
-- Once Weekly Versus Twice Weekly Carfilzomib Dosing in Patients With
Relapsed and Refractory Multiple Myeloma (A.R.R.O.W.): Efficacy and
Safety Analyzed by Age GroupAbstract #3277, Poster Presentation, Sunday,
Dec. 2 from 6 p.m. PT in San Diego Convention Center, Hall GH
-- Carfilzomib-Lenalidomide-Dexamethasone Versus
Bortezomib-Lenalidomide-Dexamethasone in Real-World Patients With Newly
Diagnosed Multiple Myeloma: Results from a Prospective, Longitudinal,
Observational Study (CoMMpass)Abstract #799, Oral Presentation, Monday,
Dec. 3 at 2:45 p.m. PT in San Diego Convention Center, Room 6F
-- Could Patients with Multiple Myeloma (MM) Derive Additional Benefit From
Their Treatments? Real World Evidence for Carfilzomib Dosing Intensity
on Survival and Treatment ProgressionAbstract #836, Oral Presentation,
Monday, Dec. 3 at 3 p.m. PT in San Diego Convention Center, Room 25B
-- A Phase 1b Study of Oprozomib with Dexamethasone or Pomalidomide and
Dexamethasone in Patients with Relapsed or Refractory Multiple
MyelomaAbstract #803, Oral Presentation, Monday, Dec. 3 at 3:45 p.m. PT
in San Diego Convention Center, Room 6F
Amgen Webcast Investor Meeting
Amgen will host a webcast investor meeting at ASH 2018 on Monday, Dec. 3 at 8 p.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate at the investor meeting to discuss Amgen's oncology program and data presented at ASH 2018.
Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About BiTE(®) Technology
Bispecific T cell engager (BiTE(®)) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient's own immune system by bridging T cells to tumor cells. BiTE(®) antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE(® )antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.
About BLINCYTO(®) (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE(®)) immunotherapy that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration (FDA) in 2014, and now carries full approval in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.
BLINCYTO is now approved in 57 countries, including all member countries in the European Union and the European Economic Area, Canada, Japan, and Australia.
BLINCYTO(®) U.S. Product Safety Information
Indication and Important Safety Information, including Boxed WARNINGS, for BLINCYTO(® )(blinatumomab) for injection, for intravenous use
INDICATION
BLINCYTO is indicated for the treatment of adults and children with:
-- 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%. This indication is approved under accelerated approval
based on MRD response rate and hematological relapse-free survival.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials.
-- Relapsed or refractory Bcell precursor acute lymphoblastic leukemia
(ALL)
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(®) 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 patients receiving BLINCYTO(®). The median time to
onset of CRS is 2 days after the start of infusion. Closely monitor
patients 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 (CLS), and hemophagocytic histiocytosis/macrophage activation
syndrome (MAS). In clinical trials of BLINCYTO, CRS was reported in 15%
of patients with relapsed or refractory ALL and in 7% of patients with
MRD-positive ALL. Interrupt or discontinue BLINCYTO(® )as outlined in
the PI.
-- 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 (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.
-- 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(®).
-- Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl
Alcohol Preservative: Serious and fatal adverse reactions including
"gasping syndrome," which is characterized by central nervous system
depression, metabolic acidosis, and gasping respirations, can occur in
neonates and infants treated with benzyl alcohol-preserved drugs
including BLINCYTO(®) (with preservative). When prescribing
BLINCYTO(®) (with preservative) for pediatric patients, consider the
combined daily metabolic load of benzyl alcohol from all sources
including BLINCYTO(®) (with preservative) and other drugs containing
benzyl alcohol. The minimum amount of benzyl alcohol at which serious
adverse reactions may occur is not known. Due to the addition of
bacteriostatic saline, 7-day bags of BLINCYTO(®) solution for infusion
with preservative contain benzyl alcohol and are not recommended for use
in any patients weighing < 22 kg.
Adverse Reactions
-- The most common adverse reactions (>= 20%) in clinical trial experience
of patients with MRD-positive B-cell precursor ALL (BLAST Study) treated
with BLINCYTO(®) were pyrexia, infusion related reactions, headache,
infections (pathogen unspecified), tremor, and chills. Serious adverse
reactions were reported in 61% of patients. The most common serious
adverse reactions (>=2%) included pyrexia, tremor, encephalopathy,
aphasia, lymphopenia, neutropenia, overdose, device related infection,
seizure, and staphylococcal infection.
-- The most common adverse reactions (>= 20%) in clinical trial experience
of patients with Philadelphia chromosome-negative relapsed or refractory
B-cell precursor ALL (TOWER Study) treated with BLINCYTO(®) were
infections (bacterial and pathogen unspecified), pyrexia, headache,
infusion-related reactions, anemia, febrile neutropenia,
thrombocytopenia, and neutropenia. Serious adverse reactions were
reported in 62% of patients. The most common serious adverse reactions
(>= 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia,
overdose, septic shock, CRS, bacterial sepsis, device related infection,
and bacteremia.
-- Adverse reactions that were observed more frequently (>= 10%) in the
pediatric population compared to the adult population were pyrexia (80%
vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%),
infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%),
leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
-- In pediatric patients less than 2 years old (infants), the incidence of
neurologic toxicities was not significantly different than for the other
age groups, but its manifestations were different; the only event terms
reported were agitation, headache, insomnia, somnolence, and
irritability. Infants also had an increased incidence of hypokalemia
(50%) compared to other pediatric age cohorts (15-20%) or adults (17%).
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 Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO(®).
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.(1) It is a rare disease that accounts for approximately two percent of all cancers.(2) Worldwide, approximately 114,000 people are diagnosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis.(2)
About KYPROLIS(®) (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.(3) KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.(4) 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.(3,4)
Since its first approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. 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, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, South Korea, Turkey, United Arab Emirates, Qatar, Switzerland, Russia, Brazil, India, Oman and additional U.S. regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
Important U.S. KYPROLIS(®) (carfilzomib) 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 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 events 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 adverse events (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. 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 hormonal contraception associated with a risk of
thrombosis should consider an alternative method of effective
contraception during treatment.
Infusion Reactions
-- Infusion reactions, including life?threatening reactions, have occurred.
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.
Premedicate with dexamethasone to reduce the incidence and severity of
infusion reactions. Inform patients of the risk and of symptoms and seek
immediate medical attention if they occur.
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.
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 events 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.
-- Females of reproductive potential should be advised to avoid becoming
pregnant while being treated with KYPROLIS and for 6 months following
the final dose. Males of reproductive potential should be advised to
avoid fathering a child while being treated with KYPROLIS and for 3
months following the final dose. 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 reactions 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 reactions 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'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.
For more information, follow us on www.twitter.com/amgenoncology.
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.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or 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. 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 acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach 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 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 relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by 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)
Andrea Fassaceisa, 805- 905-2575 (Media)
Arvind Sood, 805-447-1060 (Investors)
Velcade(®) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.
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