Aranesp (darbepoetin alfa)
/ Amgen, Kyowa Kirin
- LARVOL DELTA
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November 05, 2020
[VIRTUAL] The Commands Trial: A Phase 3 Study of the Efficacy and Safety of Luspatercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low-, Low-, or Intermediate-Risk MDS in Erythropoiesis Stimulating Agent-Naive Patients Who Require RBC Transfusions
(ASH 2020)
- P3 | "Recent studies of epoetin alfa and darbepoetin alfa have demonstrated efficacy among patients with LR-MDS, but the patient population in whom a clinically significant effect is seen may be limited (Fenaux P, et al...Exclusion criteria include prior use of ESAs (≤ 2 doses of prior epoetin alfa permitted if ≥ 8 weeks from randomization date and sEPO confirmed as ≤ 500 U/L), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for the treatment of febrile neutropenia; disease-modifying agents (e.g. lenalidomide), or hypomethylating agents; and presence of del(5q) cytogenetic abnormality...Key secondary endpoints include duration of RBC-TI, change in Hb levels, achievement of HI-E response per International Working Group (IWG) 2006 criteria, and safety. The COMMANDS trial is registered at ClinicalTrials.gov (NCT03682536) and EudraCT (number 2017-003190-34)."
Clinical • P3 data • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • CSF2 • EPO • SF3B1
August 22, 2026
Weekly Metronomic Venetoclax and Decitabine/Cedazuridine in Acute Myeloid Leukemia Patient Declining Blood Transfusion.
(PubMed, Case Rep Oncol)
- "Due to refusal of transfusions, he was treated with a metronomic, all-oral regimen of VEN 400 mg weekly and decitabine/cedazuridine (DEC-C) 35/100 mg weekly, supported by erythropoiesis-stimulating agent (darbepoetin alfa) and thrombopoietin agonist (romiplostim) as needed. This case demonstrates that a metronomic, all-oral VEN and DEC-C regimen can achieve hematologic improvement and molecular response in AML while maintaining transfusion independence. It highlights a feasible and safe therapeutic option for patients declining blood products, achieving disease control with minimal toxicity."
Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • ASXL1 • DDX41 • PPM1D
September 23, 2026
Darbepoetin alfa is more effective than epoetin-β in suppressing hepcidin and improving iron utilization in maintenance hemodialysis patients.
(PubMed, Am J Transl Res)
- "Compared to EPO-β, DA more effectively suppresses hepcidin, improves iron metabolism markers, and achieves higher erythropoietic efficiency, with comparable Hb response rates and safety profiles between the two groups."
Journal • Renal Disease • CRP
September 01, 2026
Comparative Outcomes With Luspatercept Versus Erythropoiesis-Stimulating Agents in Lower-Risk Myelodysplastic Syndromes: A Propensity Score-Matched Retrospective Cohort Study
(SOHO 2026)
- "The luspatercept cohort excluded patients with any epoetin alfa or darbepoetin alfa exposure; the ESA cohort excluded patients with any luspatercept exposure. In this propensity score–matched real-world cohort of patients with lower-risk MDS, luspatercept was associated with lower mortality, venous thromboembolism, heart failure, and infection hospitalization, when compared to ESAs, without higher transfusion use or increased transition to hypomethylating therapy. Prospective studies are needed to validate these findings. CI: confidence interval, HR: hazard ratio, ICD-10-CM: International Classification of Diseases, Tenth Revision, Clinical Modification."
Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
August 29, 2026
A Silent Culprit: Sporadic Peutz-Jeghers Polyp as the Etiology of Chronic Iron Deficiency Anemia
(ACG 2026)
- "He had documented microcytic IDA since 2018 (ferritin nadir 4 ng/mL), requiring recurrent IV iron and darbepoetin alfa, without overt bleeding...This case underscores VCE as an indispensable tool in persistent unexplained IDA when standard bidirectional endoscopy is unrevealing, enabling tissue diagnosis, precise localization, and curative surgical resection. Given the uncertain malignant potential of sporadic PJ polyps, genetic counseling and long-term surveillance may be appropriate."
Anemia • Chronic Kidney Disease • Embryonal Tumor • Gastrointestinal Disorder • Infectious Disease • Type 2 Diabetes Mellitus • CEACAM5 • MUC16 • STK11
July 15, 2026
DUAL APPROACH TO ANEMIA IN PANCREATIC CANCER: DARBEPOETIN ALFA AND INTRAVENOUS IRON SUPPLEMENTATION – RETROSPECTIVE STUDY
(UEGW 2026)
- No abstract available
Retrospective data • Anemia • Oncology • Pancreatic Cancer • Solid Tumor
August 26, 2026
UCOE-Mediated Transcriptional Stabilization Combined with EGFP-Based FACS Screening Enables Efficient Selection of High-Producing CHO Cells.
(PubMed, Mol Biotechnol)
- "Here, we have used the combined strategy of FACS-based screening and UCOE to accelerate the clonal selection and enhance recombinant Darbepoetin alfa (DPO) productivity in Chinese Hamster Ovary (CHO) cells...This study demonstrated that UCOE-mediated transcriptional stabilization establishes a robust expression framework while EGFP-based FACS screening enables efficient enrichment of high-producing cells. Combining them enhances protein yield with potential for further optimization in larger-scale applications."
Journal • DHFR
July 28, 2026
Adsorption characteristics of erythropoietin in two β2-microglobulin absorption systems: a preliminary in vitro study using FILTOR® and Lixelle®.
(PubMed, J Artif Organs)
- "The FILTOR® adsorption device showed greater reductions in erythropoietin concentration than the Lixelle® device in experiments using EPO. A similar trend was observed for DA, whereas no apparent difference was observed for C.E.R.A. Because DA and C.E.R.A. were evaluated using assay cross-reactivity, and quantitative assessment was limited by the sampling strategy, these findings should be interpreted with caution."
Journal • Preclinical • Amyloidosis • B2M
July 18, 2026
Evaluation of Anemia Management in a Contemporary Population of Patients With Chronic Kidney Disease in Canada Since the Publication of Target Hemoglobin Trials: A Retrospective Observational Cohort Study.
(PubMed, Can J Kidney Health Dis)
- "The dose of ESA was quantified as an average monthly dose of epoetin alfa or darbepoetin alfa. Despite a minority of patients meeting criteria for prior hemoglobin target trials, the universal adoption of guidelines favoring a conservative approach to anemia has culminated in a higher likelihood of patients experiencing severe anemia. The implications of this, particularly patient-reported outcomes, warrant further investigation."
Journal • Observational data • Retrospective data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease
July 09, 2026
Efficacy, safety, and dose selection of efepoetin alfa in anemic patients on maintenance dialysis: a phase 2, randomized, multicenter, active-controlled trial.
(PubMed, Kidney Res Clin Pract)
- "Over 12 weeks, HD patients received intravenous efepoetin alfa (5 or 8 µg/kg once weekly [Q1W], 8 µg/kg every 2 weeks [Q2W]) or darbepoetin alfa (30 µg Q1W). PD patients received subcutaneous efepoetin alfa (5 or 8 µg/kg Q2W) or methoxy polyethylene glycol-epoetin beta (0.6 µg/kg Q2W)...Exploratory DCR analysis supported 4 µg/kg Q2W efepoetin alfa as the phase 3 starting dose. Efepoetin alfa demonstrated dose-dependent erythropoietic efficacy and an acceptable safety profile in dialysis patients, supporting dose-range characterization and phase 3 starting dose selection."
Journal • P2 data • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease
July 13, 2026
Negative correlation between serial changes in the reticulocyte number and C-reactive protein level in dogs with delayed reticulocytosis.
(PubMed, J Vet Med Sci)
- "Similarly, erythropoietic responses to darbepoetin alfa appeared to be attenuated in dogs with elevated CRP concentrations. In these dogs, whose mean CRP concentration was 6.15 mg/dL, the onset of reticulocytosis was delayed approximately twofold, and the increase in peak reticulocyte count was approximately 38% lower than that in dogs with normal CRP concentrations. This study provides clinical evidence supporting an association between systemic inflammation and reduced or delayed reticulocytosis in dogs, highlighting the clinical utility of concurrently monitoring CRP and reticulocyte levels to assess disease progression and inflammatory recovery."
Journal • Hematological Disorders • Inflammation • CRP
June 17, 2026
Characteristics of Darbepoetin Alfa Dosing Optimization in Solid Organ Transplant Recipients
(ATC 2026)
- "Most DA orders for SOT recipients at a large volume transplant center were inappropriate, primarily due to doses exceeding weight-based recommendations. These findings identify clear opportunities for prescribing optimization, specifically initial selected dose. Ongoing initiatives include provider education and protocol development, with follow-up analyses planned to assess impact on dosing appropriateness, transfusion rates, and cost outcomes.DA Doses Stratified by Appropriateness Including Reason InappropriateDose # 1 (n=122)Dose #2 (n=23)Dose #3 (n=8)Appropriate dose (%)10 (8)0 (0)0 (0)Inappropriate dose (%)112 (92)23 (100)8 (100)Interval 10 g/dL1 (1)4 (17)0 (0)Dose > 0.45 mcg/kg1 (1)2 (9)2 (25)"
Clinical • Hematological Disorders • Solid Organ Transplantation • Transplantation
May 12, 2026
REAL WORLD USE OF ERYTHROPOIESIS STIMULATING AGENTS IN PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY IN EUROPE
(EHA 2026)
- "Long-acting ESA: darbepoetin alfa; short-acting ESA: epoetin alfa, beta, theta, and zeta. SD (standard deviation). °Index date (Day 0) was the first recorded ESA prescription date."
Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor
April 13, 2026
Cost-effectiveness evaluation of renal anemia treatment with the use of HIF-PF inhibitors
(ERA 2026)
- "Method In 31 outpatient hemodialysis patients (22 males, 9 females, mean age 70.2 years, average dialysis history 81 months) who maintained Hb concentrations ≥ 11.0 g/dL for more than half a year with ESA preparation (Darbepoetin alfa 10 μ ~ 20 μ /week) were treated with HIF-PH inhibitors (Daprodustat 6mg) after obtaining written consent, were taken orally on the day of dialysis treatment, and the cost reduction effect and anemia maintenance effect (change in Hb concentration) were examined for 6 months before and 6 months after administration. It is important to treat renal anemia considering the patient's pathological conditions and medical drug price. Image"
Cost effectiveness • HEOR • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease
April 13, 2026
Impact of a Proactive High-Dose Intravenous Iron Protocol in Haemodialysis unit: A Closed-Loop quality Improvement Audit
(ERA 2026)
- "Outcomes include ferritin, TSAT, haemoglobin (Hb), ESA dosage (darbepoetin alfa), and transfusion requirements...However, contrary to pivotal trial data (PIVOTAL), ESA requirements increased in the short term, and TSAT levels did not improve, suggesting a lag in physiological response or unaddressed inflammation. Future cycles will incorporate a formal ESA de-escalation."
Clinical • Inflammation
April 13, 2026
Roxadustat versus Darbepoetin Alfa in Post–Kidney Transplant anemia management: A Multicenter Italian Comparative Study
(ERA 2026)
- No abstract available
Clinical • Anemia • Hematological Disorders • Transplantation
June 13, 2026
Expert Consensus Guidelines for Chemotherapy-Induced Anemia Management and Role of Darbepoetin Alfa in Solid Tumour Patients: An Indian Perspective
(MASCC-ISOO 2026)
- "Conclusions In clinical practice it's important to understand when to use darbepoetin alfa and when to give blood transfusion for cancer anemia management. This consensus states that it should be based on anemia severity, symptoms, iron status, treatment intent while balancing safety and continuity of cancer therapy."
Clinical • Anemia • Chemotherapy-Induced Anemia • Oncology • Solid Tumor
June 10, 2026
Site-specific enrichment of highly sialylated N-glycans in an erythropoietin-hybrid Fc fusion protein.
(PubMed, Eur J Pharm Biopharm)
- "Erythropoietin-hybrid Fc fusion protein (EPO-hyFc), comprising an EPO domain fused to a hybrid IgD-IgG4 Fc, is a next-generation erythropoiesis-stimulating agent with an approximately two-fold longer serum half-life than darbepoetin alfa, a clinically established long-acting EPO formulation...The average number of sialic acids per N-glycan was 2.2, and the sialic acid-capping ratio was 90.9%, indicating extensive terminal sialylation across the EPO sites. These results provide the first site-specific characterization of N-glycosylation in EPO-hyFc and offer structural and quantitative insights for optimizing its stability, pharmacokinetics, and therapeutic efficacy."
Journal
June 12, 2026
A comparative study of PiggyBac-mediated gene insertion and ubiquitous chromatin opening element incorporation to enhance Darbepoetin alfa expression.
(PubMed, 3 Biotech)
- "Compared with the semi-targeted transposition method, UCOE incorporation further increased Darbepoetin alfa production by ~ 2.5-fold. The online version contains supplementary material available at 10.1007/s13205-026-04828-6."
Journal
June 10, 2026
Eryhtropoetin induced 18F-PSMA-11 bone marrow sink effect.
(PubMed, Eur J Nucl Med Mol Imaging)
- "The effect of erythropoietin on bone marrow mobilization and neovascularization can persist for 7-10 days [5]. This should be taken into consideration in order to avoid erroneous interpretation of 18F-PMSA-11 PET/CT imaging and unnecessary bone marrow toxicity of 177Lu-PSMA-617 treatment."
Journal • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Renal Disease • Solid Tumor
April 21, 2026
Comparative outcomes of red blood cell transfusion versus erythropoiesis-stimulating agents in lung cancer patients with chemotherapy-induced anemia: A real-world analysis.
(ASCO 2026)
- "Participants were stratified by receipt of RBC transfusion or ESA therapy (epoetin alfa, darbepoetin alfa, or methoxy polyethylene glycol-epoetin beta). In this real-world analysis, ESA therapy was associated with lower risks of sepsis and myocardial infarction, but a higher incidence of brain metastases, potentially due to erythropoietin receptor-mediated tumor progression. These findings may inform individualized risk-benefit discussions when selecting anemia management strategies in lung cancer. Prospective studies are needed to validate these associations."
Clinical • Real-world • Real-world evidence • Anemia • Chemotherapy-Induced Anemia • Infectious Disease • Lung Cancer • Myocardial Infarction • Oncology • Pulmonary Embolism • Respiratory Diseases • Septic Shock • Solid Tumor
May 27, 2026
DIVI: Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
(clinicaltrials.gov)
- P2 | N=120 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Oct 2026 ➔ Jan 2027
Trial primary completion date • Anemia • Hematological Disorders
May 23, 2026
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
(clinicaltrials.gov)
- P3 | N=429 | Recruiting | Sponsor: Genexine, Inc. | Trial completion date: Sep 2027 ➔ Mar 2028 | Trial primary completion date: Dec 2026 ➔ Jun 2027
Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease
May 19, 2026
Erythropoiesis-stimulating agent resistance is associated with diabetic kidney disease but not with diabetes: a post hoc analysis of the BRIGHTEN study.
(PubMed, Clin Exp Nephrol)
- "Although diabetes alone was not associated with ESA resistance, patients with DKD exhibited higher resistance, suggesting that ESA resistance is more closely linked to DKD than to diabetes itself. These findings highlight the role of proteinuria and inflammation in the ESA response, emphasizing the need for individualized anemia management strategies based on nephropathy type."
Journal • Retrospective data • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hematological Disorders • Inflammation • Metabolic Disorders • Nephrology • Renal Disease
May 19, 2026
Darbepoetin alfa for the treatment of anemia in myelodysplastic syndromes: a post-marketing surveillance study in Japan.
(PubMed, Int J Hematol)
- "Poor prognostic factors for MDS were IPSS risk category, age, chromosomal abnormalities, and platelet count. No new safety or effectiveness concerns were identified.Trial registration: University Hospital Medical Information Network; study ID: UMIN000056049."
Journal • P4 data • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Oncology • Pneumonia • Respiratory Diseases
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