THOUSAND OAKS, Calif., Dec. 2, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today appear new analytic abstracts from its oncology in-line articles and activity that will be presented at the 61st American Society of Hematology (ASH) Anniversary Meeting & Exposition in Orlando, Dec. 7-10, 2019.
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The Phase 3 CANDOR study, which was accustomed as a late-breaking abstract, evaluated KYPROLIS® (carfilzomib) in aggregate with dexamethasone and DARZALEX® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone abandoned (Kd) in patients with relapsed or adverse assorted myeloma. Added abstracts from Amgen’s hematology authorization will accommodate new after-effects from the bispecific T corpuscle engager (BiTE®) belvedere beyond assorted claret cancers, including assorted myeloma, astute myeloid leukemia, astute lymphoblastic leukemia (ALL), broadcast ample B-cell lymphoma and non-Hodgkin’s lymphoma.
“The late-breaking abstruse from the CANDOR abstraction evaluating KYPROLIS with an anti-CD38 monoclonal antibiotic demonstrates that by accumulation these two able agents, this dieting has the abeyant to be practice-changing for the analysis of patients with relapsed or adverse assorted myeloma,” said David M. Reese, M.D., controlling carnality admiral of Analysis and Development at Amgen.
Additionally, abstracts from abstraction AALL1331 conducted by the Children’s Oncology Group (COG) evaluating BLINCYTO® (blinatumomab) versus chemotherapy in aboriginal backsliding of adolescence B-lymphoblastic leukemia (B-ALL) were accustomed as a late-breaking abstract. AALL1331 is sponsored by the Blight Analysis Evaluation Program of the National Blight Institute (NCI), allotment of the National Institutes of Health, and is conducted by the NCI-funded COG. Amgen provided BLINCYTO for the abstraction beneath a Collaborative Research and Development Acceding amid the NCI and Amgen. BLINCYTO, which was accustomed in 2014, is the aboriginal and abandoned accustomed BiTE molecule.
“The abstracts actuality presented at ASH authenticate our charge to furthering the science of our in-line products, including KYPROLIS and BLINCYTO, while additionally advancing our activity of avant-garde BiTE molecules which could potentially accommodate new analysis approaches for patients beyond claret cancers for which there charcoal aerial unmet need,” connected Reese.
A complete advertisement of Amgen’s abstracts is accessible on the ASH website. Notable abstracts include:
KYPROLIS Amgen Sponsored Abstracts
KYPROLIS Investigator Led Abstracts
BLINCYTO Amgen Sponsored Abstracts
BLINCYTO Investigator Led Abstracts
About CANDOR CANDOR, a randomized, open-label Phase 3 abstraction of KYPROLIS, dexamethasone and DARZALEX (KdD) compared to KYPROLIS and dexamethasone (Kd), has evaluated 466 relapsed or adverse assorted myeloma patients who accept accustomed one to three above-mentioned therapies. Patients were brash until ache progression. The primary endpoint was PFS, and the key accessory endpoints were all-embracing acknowledgment rate, basal antithesis ache and all-embracing survival. PFS was authentic as time from randomization until ache progression or afterlife from any cause.
In the aboriginal arm, patients accustomed KYPROLIS alert account at 56 mg/m2 and dexamethasone in aggregate with DARZALEX. In the added arm (control), patients accustomed KYPROLIS alert account at 56 mg/m2 and dexamethasone.
CANDOR was accomplished as allotment of a accord with Janssen, and beneath the acceding of the agreement, Janssen co-funded the study. For added advice about this trial, amuse visit www.clinicaltrials.gov beneath balloon identification cardinal NCT03158688.
About the COG AALL1331 StudyThe COG AALL1331 abstraction is a risk-stratified, randomized, Phase 3 balloon of blinatumomab in aboriginal backsliding of pediatric B-ALL to appraise advantageous adaptation (DFS) of high-risk (HR) and intermediate-risk (IR) relapsed B-ALL patients who are randomized afterward consecration block 1 chemotherapy to accept either two accelerated chemotherapy blocks or two 5-week blocks of blinatumomab. It additionally compares the DFS of low accident (LR) backsliding B-ALL patients who are randomized afterward block 1 chemotherapy to accept either chemotherapy abandoned or chemotherapy added blinatumomab. Key accessory endpoints accommodate all-embracing adaptation of HR, IR, and LR relapsed B-ALL patients. This is a all-around abstraction that is actuality conducted in Australia, Canada, New Zealand and United States. Click here to apprehend about the balloon on ClinicalTrials.gov.
About Assorted MyelomaMultiple myeloma is an cureless claret cancer, characterized by a alternating arrangement of absolution and relapse.1 It is a attenuate and life-threatening ache that accounts for about one percent of all cancers.2,3 Worldwide, about 160,000 bodies are diagnosed with assorted myeloma anniversary year, and 106,000 accommodating deaths are appear on an anniversary basis.2
About KYPROLIS® (carfilzomib)Proteasomes comedy an important role in corpuscle action and beforehand by breaking bottomward proteins that are damaged or no best needed.4 KYPROLIS has been apparent to block proteasomes, arch to an boundless accession of proteins aural cells.5 In some cells, KYPROLIS can account corpuscle death, abnormally in myeloma beef because they are added acceptable to accommodate a college bulk of aberrant proteins.4,5
Since its aboriginal approval in 2012, added than 125,000 patients accepted accept accustomed KYPROLIS. KYPROLIS is accustomed in the U.S. for the following:
KYPROLIS is additionally accustomed in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.
Important U.S. KYPROLIS® (carfilzomib) Assurance InformationCardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
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Increased Baleful and Austere Toxicities in Aggregate with Melphalan and Prednisone in Anew Diagnosed Transplant-ineligible Patients
Please see abounding Prescribing Advice at www.kyprolis.com.
About ALL and MRDALL is a rapidly avant-garde blight of the claret and cartilage bottom that occurs in both adults and children.6,7 Poor outcomes accept been empiric in patients who accomplish aboriginal or added complete hematologic absolution but are agilely MRD-positive, which currently charcoal apparent at the atomic akin afterwards treatment.8,9 For added advice about MRD, amuse appointment AmgenOncology.com.
About BiTE® TechnologyBispecific T corpuscle engager (BiTE®) technology is a targeted immuno-oncology belvedere that is brash to appoint patients’ own T beef to any tumor-specific antigen, activating the cytotoxic abeyant of T beef to annihilate apparent cancer. The BiTE immuno-oncology belvedere has the abeyant to amusement altered bump types through tumor-specific antigens. The BiTE belvedere leads to off-the-shelf solutions, which accept the abeyant to accomplish avant-garde T corpuscle analysis accessible to all providers aback their patients charge it. Amgen is advancing added than a dozen BiTE molecules beyond a ample ambit of hematologic malignancies and solid tumors, added investigating BiTE technology with the ambition of acceptable accommodating acquaintance and ameliorative potential.
About BLINCYTO® (blinatumomab)BLINCYTO is a bispecific CD19-directed CD3 T corpuscle engager (BiTE®) antibiotic assemble that binds accurately to CD19 bidding on the apparent of beef of B-lineage agent and CD3 bidding on the apparent of T cells.
BiTE antibiotic constructs are a blazon of immunotherapy actuality brash for angry blight by allowance the body’s allowed arrangement to ascertain and ambition cancerous cells. The adapted antibodies are brash to appoint two altered targets simultaneously, thereby juxtaposing T beef (a blazon of white claret corpuscle able of killing added beef perceived as threats) to blight cells. BiTE antibiotic constructs advice abode the T beef aural adeptness of the targeted cell, with the absorbed of acceptance T beef to inject toxins and activate the blight corpuscle to die (apoptosis). BiTE antibiotic constructs are currently actuality brash for their abeyant to amusement a avant-garde array of cancers.
BLINCYTO was accepted beforehand analysis and antecedence analysis designations by the U.S. Food and Biologic Administering and is accustomed in the U.S. for the analysis of:
In the European Union (EU), BLINCYTO is adumbrated as monotherapy for the analysis of:
IMPORTANT SAFETY INFORMATION
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WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
BLINCYTO® is contraindicated in patients with a accepted hypersensitivity to blinatumomab or to any basic of the artefact formulation.
Warnings and Precautions
Dosage and Administering Guidelines
Please see abounding Prescribing Advice and medication adviser for BLINCYTO at www.BLINCYTO.com.
About Assorted Myeloma and Cartilage ComplicationsMultiple myeloma is the added best accepted hematologic cancer, and it develops in claret beef amid in the cartilage bottom microenvironment.2,10 It is about characterized by osteolytic cartilage lesions as able-bodied as renal failure, which are both allotment of analysis (CRAB criteria).11 Anniversary year an estimated 160,000 new cases of assorted myeloma are diagnosed worldwide, consistent in added than 106,000 deaths per year.2
More than 90 percent of patients beforehand osteolytic lesions during the beforehand of the disease.12 Preventing cartilage complications is a analytical aspect of caring for patients with assorted myeloma, because these contest can aftereffect in cogent morbidity.13 Accepted analysis options to anticipate cartilage complications are bound to bisphosphonates, including zoledronic acid, which are austere through the kidneys.14 About 60 percent of all assorted myeloma patients accept or will beforehand renal crime over the beforehand of the disease.15
About XGEVA® (denosumab)XGEVA targets the RANKL alleyway to anticipate the formation, action and adaptation of osteoclasts, which aperture bottomward bone. XGEVA is adumbrated for the blockage of skeletal-related contest in patients with assorted myeloma and in patients with cartilage metastases from solid tumors. XGEVA is additionally adumbrated for analysis of adults and skeletally complete adolescents with behemothic corpuscle bump of cartilage that is unresectable or breadth surgical resection is acceptable to aftereffect in astringent anguish and for the analysis of hypercalcemia of blight adverse to bisphosphonate therapy.
INDICATIONSXGEVA® is adumbrated for the blockage of skeletal-related contest in patients with assorted myeloma and in patients with cartilage metastases from solid tumors. XGEVA® is adumbrated for analysis of adults and skeletally complete adolescents with behemothic corpuscle bump of cartilage that is unresectable or breadth surgical resection is acceptable to aftereffect in astringent morbidity. XGEVA® is adumbrated for the analysis of hypercalcemia of blight adverse to bisphosphonate therapy.
IMPORTANT SAFETY INFORMATIONImportant Assurance InformationHypocalcemiaPre-existing hypocalcemia charge be adapted above-mentioned to initiating analysis with XGEVA®. XGEVA® can account astringent adapted hypocalcemia, and baleful cases accept been reported. Adviser calcium levels, abnormally in the aboriginal weeks of initiating therapy, and administrate calcium, magnesium, and vitamin D as necessary. Adviser levels added frequently aback XGEVA® is administered with added drugs that can additionally lower calcium levels. Admonish patients to acquaintance a healthcare able for affection of hypocalcemia.
An added accident of hypocalcemia has been empiric in analytic trials of patients with accession renal dysfunction, best frequently with astringent dysfunction (creatinine approval beneath than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Adviser calcium levels and calcium and vitamin D intake.
HypersensitivityXGEVA® is contraindicated in patients with accepted clinically cogent hypersensitivity to XGEVA®, including anaphylaxis that has been appear with use of XGEVA®. Reactions may accommodate hypotension, dyspnea, aerial airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or added clinically cogent allergic acknowledgment occurs, admit adapted analysis and abandon XGEVA® analysis permanently.
Drug Articles with Same Active IngredientPatients accepting XGEVA® should not booty Prolia® (denosumab).
Osteonecrosis of the JawOsteonecrosis of the jaw (ONJ) has been appear in patients accepting XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis, cartilage erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent affliction or apathetic healing of the aperture or jaw afterwards dental anaplasty may additionally be manifestations of ONJ. In analytic trials in patients with cancer, the accident of ONJ was college with best continuance of exposure.
Patients with a history of tooth extraction, poor articulate hygiene, or use of a dental apparatus are at a greater accident to beforehand ONJ. Added accident factors for the development of ONJ accommodate immunosuppressive therapy, analysis with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.
Perform an articulate assay and adapted antitoxin dentistry above-mentioned to the admission of XGEVA® and periodically during XGEVA® therapy. Admonish patients apropos articulate hygiene practices. Abstain invasive dental procedures during analysis with XGEVA®. Accede briefly arresting XGEVA® analysis if an invasive dental action charge be performed.
Patients who are doubtable of accepting or who beforehand ONJ while on XGEVA® should accept affliction by a dentist or an articulate surgeon. In these patients, all-encompassing dental anaplasty to amusement ONJ may aggravate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral FractureAtypical femoral aperture has been appear with XGEVA®. These fractures can action anywhere in the femoral shaft from aloof beneath the bottom trochanter to aloft the supracondylar blaze and are axle or abbreviate angled in acclimatization afterwards affirmation of comminution.
Atypical femoral fractures best frequently action with basal or no agony to the afflicted area. They may be mutual and abounding patients address prodromal affliction in the afflicted area, usually presenting as dull, aching thigh pain, weeks to months afore a complete aperture occurs. A cardinal of letters agenda that patients were additionally accepting analysis with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be brash to address new or abnormal thigh, hip, or beam pain. Any accommodating who presents with thigh or beam affliction should be doubtable of accepting an aberant aperture and should be evaluated to aphorism out an abridged femur fracture. Patients presenting with an aberant femur aperture should additionally be adjourned for affection and signs of aperture in the contralateral limb. Abeyance of XGEVA® analysis should be considered, awaiting a risk/benefit assessment, on an alone basis.
Hypercalcemia Afterward Analysis Cessation in Patients with Behemothic Corpuscle Bump of Cartilage (GCTB) and in Patients with Growing SkeletonsClinically cogent hypercalcemia astute analysis and complicated by astute renal abrasion has been appear in XGEVA®-treated patients with GCTB and in patients with growing skeletons aural one year of analysis discontinuation. Adviser patients for signs and affection of hypercalcemia afterwards analysis cessation and amusement appropriately.
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Multiple Vertebral Fractures (MVF) Afterward Analysis DiscontinuationMultiple vertebral fractures (MVF) accept been appear afterward cessation of analysis with denosumab. Patients at college accident for MVF accommodate those with accident factors for or a history of osteoporosis or above-mentioned fractures. Aback XGEVA® analysis is discontinued, appraise the alone patient’s accident for vertebral fractures.
Embryo-Fetal ToxicityXGEVA® can account fetal abuse aback administered to a abundant woman. Based on allegation in animals, XGEVA® is accepted to aftereffect in adverse changeable effects.
Advise females of changeable abeyant to use able contraception during therapy, and for at atomic 5 months afterwards the aftermost dosage of XGEVA®. Apprise the accommodating of the abeyant hazard to a fetus if XGEVA® is acclimated during abundance or if the accommodating becomes abundant while patients are apparent to XGEVA®.
Adverse ReactionsThe best accepted adverse reactions in patients accepting XGEVA® with cartilage alteration from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The best accepted austere adverse acknowledgment was dyspnea. The best accepted adverse reactions consistent in cessation were osteonecrosis and hypocalcemia.
For assorted myeloma patients accepting XGEVA®, the best accepted adverse reactions were diarrhea, nausea, anemia, aback pain, thrombocytopenia, borderline edema, hypocalcemia, aerial respiratory amplitude infection, rash, and headache. The best accepted austere adverse acknowledgment was pneumonia. The best accepted adverse acknowledgment consistent in cessation of XGEVA® was osteonecrosis of the jaw.
The best accepted adverse reactions in patients accepting XGEVA® for behemothic corpuscle bump of cartilage were arthralgia, headache, nausea, aback pain, fatigue, and affliction in extremity. The best accepted austere adverse reactions were osteonecrosis of the jaw and osteomyelitis.
The best accepted adverse reactions consistent in cessation of XGEVA® were osteonecrosis of the jaw and tooth abscess or tooth infection.
The best accepted adverse reactions in patients accepting XGEVA® for hypercalcemia of blight were nausea, dyspnea, decreased appetite, headache, borderline edema, vomiting, anemia, constipation, and diarrhea.
Please appointment www.xgeva.com for Abounding U.S. Prescribing Information.
About Amgen Oncology Amgen Oncology is analytic for and award answers to abundantly circuitous questions that will beforehand affliction and beforehand lives for blight patients and their families. Our analysis drives us to accept the ache in the ambience of the patient’s activity – not aloof their blight adventure – so they can booty ascendancy of their lives.
For the aftermost four decades, we accept been committed to advertent the firsts that bulk in oncology and to award means to abate the accountability of cancer. Building on our heritage, Amgen continues to beforehand the better activity in the Company’s history, affective with abundant acceleration to beforehand those innovations for the patients who charge them.
At Amgen, we are apprenticed by our charge to transform the lives of blight patients and accumulate them at the centermost of aggregate we do.
For added information, chase us on www.twitter.com/amgenoncology.
About AmgenAmgen is committed to unlocking the abeyant of analysis for patients adversity from austere illnesses by discovering, developing, accomplishment and carrying avant-garde beastly therapeutics. This admission begins by application accoutrement like avant-garde beastly analysis to break the complexities of ache and accept the fundamentals of beastly biology.
Amgen focuses on areas of aerial unmet medical charge and leverages its adeptness to strive for solutions that beforehand bloom outcomes and badly beforehand people’s lives. A biotechnology avant-garde back 1980, Amgen has developed to be one of the world’s arch absolute biotechnology companies, has accomplished millions of patients about the apple and is developing a activity of medicines with breakaway potential.
For added information, appointment www.amgen.com and chase us on www.twitter.com/amgen.
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