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Myelodysplastic Syndrome

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1. Decitabine (Dacogen) - myelodysplastic syndrome (MDS)

Decitabine (Dacogen) - myelodysplastic syndrome (MDS) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1

2020 Health Canada - Drug and Health Product Register

2. Cegfila (previously Pegfilgrastim Mundipharma) - chronic myeloid leukaemia or with myelodysplastic syndromes

and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection). Pegfilgrastim Mundipharma is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia). Pegfilgrastim Mundipharma is a ‘biosimilar medicine’. This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference (...) Cegfila (previously Pegfilgrastim Mundipharma) - chronic myeloid leukaemia or with myelodysplastic syndromes Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. EMA/610120/2019 EMEA/H

2020 European Medicines Agency - EPARs

3. Azacitidine Mylan - myelodysplastic syndromes, chronic myelomonocytic leukaemia, acute myeloid leukaemia

/004984 Azacitidine Mylan (azacitidine) An overview of Azacitidine Mylan and why it is authorised in the EU What is Azacitidine Mylan and what is it used for? Azacitidine Mylan is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient’s bone marrow is replaced to form new bone marrow that produces healthy cells): • myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells (...) Azacitidine Mylan - myelodysplastic syndromes, chronic myelomonocytic leukaemia, acute myeloid leukaemia Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/66669/2020 EMEA/H/C

2020 European Medicines Agency - EPARs

4. Azacitidine betapharm - myelodysplastic syndromes, chronic myelomonocytic leukaemia, acute myeloid leukaemia

/005075 Azacitidine betapharm (azacitidine) An overview of Azacitidine betapharm and why it is authorised in the EU What is Azacitidine betapharm and what is it used for? Azacitidine betapharm is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient’s bone marrow is replaced to form new bone marrow that produces healthy cells): • myelodysplastic syndromes, a group of conditions where the bone marrow produces (...) Azacitidine betapharm - myelodysplastic syndromes, chronic myelomonocytic leukaemia, acute myeloid leukaemia Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/66667/2020 EMEA/H/C

2020 European Medicines Agency - EPARs

5. Azacitidine Celgene - myelodysplastic syndrome, chronic myelomonocytic leukaemia, acute myeloid leukaemia

/005300 Azacitidine Celgene (azacitidine) An overview of Azacitidine Celgene and why it is authorised in the EU What is Azacitidine Celgene and what is it used for? Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells): • myelodysplastic syndromes, a group of conditions where too few blood cells (...) myelodysplastic syndromes, CMML or AML who were unlikely to go on to have a stem cell transplant. The patients’ bone marrow contained up to 30% abnormal cells. In this study, patients receiving Azacitidine Celgene survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care. The effect of Azacitidine Celgene was similar in all three diseases. In the second study, which involved 488 patients with AML who could not have haematopoietic stem cell transplantation

2019 European Medicines Agency - EPARs

6. Decitabine (Demylocan) - myelodysplastic syndromes (MDS)

Decitabine (Demylocan) - myelodysplastic syndromes (MDS) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1

2019 Health Canada - Drug and Health Product Register

8. Demylocan for Myelodysplastic Syndromes – Details

Demylocan for Myelodysplastic Syndromes – Details Demylocan for Myelodysplastic Syndromes – Details | CADTH.ca Find the information you need Demylocan for Myelodysplastic Syndromes – Details Demylocan for Myelodysplastic Syndromes – Details Brand Name Demylocan Generic Name Decitabine Tumour Type Other Indication Myelodysplastic Syndromes Review Status Not Filed Manufacturer Pharmascience Inc. Submission Type Non-Submission Clarification CADTH is unable to recommend reimbursement

2019 CADTH - Pan Canadian Oncology Drug Review

9. Epoetin alfa (Eprex) - treatment of symptomatic anaemia (haemoglobin concentration of ?10g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS)

Epoetin alfa (Eprex) - treatment of symptomatic anaemia (haemoglobin concentration of ?10g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) Published 11 March 2019 Statement of advice SMC2164 epoetin alfa 2,000 / 4,000 / 10,000 / 40,000 international units per mL solution for injection in pre-filled syringe (Eprex®) Janssen-Cilag Limited 8 February 2019 ADVICE: in the absence of a submission from the holder of the marketing authorisation epoetin alfa (Eprex (...) ®) is not recommended for use within NHSScotland. Indication under review: treatment of symptomatic anaemia (haemoglobin concentration of =1 0g/ dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL). The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may

2019 Scottish Medicines Consortium

10. Myelodysplastic syndrome

Myelodysplastic syndrome Myelodysplastic syndrome - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Myelodysplastic syndrome Last reviewed: February 2019 Last updated: November 2017 Summary Heterogeneous group of clonal stem cell disorders, characterised by ineffective haematopoiesis. Primarily a disease of older adults. Can present with symptoms of anaemia, leukopenia, and thrombocytopenia, but often found during (...) a prolonged course with anaemia and neutropenic infections, or may progress rapidly to acute myelogenous leukaemia (AML). However, most patients die of infection while in the myelodysplastic syndrome (MDS) stage of their disease. Definition Myelodysplastic syndrome (MDS) is a group of clonal stem cell disorders, characterised by ineffective and dysplastic haematopoiesis resulting in 1 or more cytopenias, and a varying predilection to develop acute myeloid leukaemia (AML). Arber DA, Orazi A, Hasserjian R

2017 BMJ Best Practice

11. Conditioning intensity in secondary AML with prior myelodysplastic syndrome/myeloproliferative disorders: an EBMT ALWP study Full Text available with Trip Pro

Conditioning intensity in secondary AML with prior myelodysplastic syndrome/myeloproliferative disorders: an EBMT ALWP study Patients with secondary AML (sAML) with antecedent myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPNs) tend to have high-risk disease based on the older age of patients, high-risk cytogenetics, and higher number of prior treatments. Allogeneic hematopoietic cell transplant (HCT) is the only potentially curative therapy available. Eight hundred and two (...) survival (OS) was 46%, nonrelapse mortality (NRM) was 23%, and chronic graft-versus-host disease (cGVHD) was 39%. In univariate analysis, a statistical difference between conditioning regimens 6 months after HCT in favor of the MAC group was noted with regard to RI (hazard ratio [HR], 1.47; P = .03), LFS (HR, 1.43; P = .01), and OS (HR, 1.55; P < .05). There was no difference in the cumulative incidence of NRM (HR, 1.38; P = .15). This effect was similarly seen in multivariate analysis (MVA

2018 Blood advances

12. Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial. (Abstract)

Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial. Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies.To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS.Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602).60

2020 Annals of Internal Medicine

13. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. Full Text available with Trip Pro

Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. Patients with anemia and lower-risk myelodysplastic syndromes in whom erythropoiesis-stimulating agent therapy is not effective generally become dependent on red-cell transfusions. Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study.In a double-blind, placebo-controlled, phase 3 trial, we randomly (...) assigned patients with very-low-risk, low-risk, or intermediate-risk myelodysplastic syndromes (defined according to the Revised International Prognostic Scoring System) with ring sideroblasts who had been receiving regular red-cell transfusions to receive either luspatercept (at a dose of 1.0 up to 1.75 mg per kilogram of body weight) or placebo, administered subcutaneously every 3 weeks. The primary end point was transfusion independence for 8 weeks or longer during weeks 1 through 24, and the key

2020 NEJM

14. Hematopoietic cell transplant for acute myeloid leukemia and myelodysplastic syndrome: conditioning regimen intensity Full Text available with Trip Pro

Hematopoietic cell transplant for acute myeloid leukemia and myelodysplastic syndrome: conditioning regimen intensity In this study, we sought to identify specific individual high-intensity or reduced-intensity conditioning regimens with the best relapse-free survival (RFS) rather than the global high- vs reduced-intensity regimen comparison. Patients (median age, 58 years) with acute myeloid leukemia (AML; n = 1258), who were in first or subsequent remission, or with MDS (n = 951) who had (...) refractory anemia with unilineage or multilineage dysplasia, 5q- syndrome, or refractory anemia with excess blasts received nonirradiation-containing regimens and were transplanted between 2009 and 2014 in the United States. Three-year RFS with high-intensity busulfan/cyclophosphamide (Bu4/Cy; 44%) was comparable to conditioning with high-intensity fludarabine/busulfan (Flu/Bu4; 44%), reduced-intensity fludarabine/melphalan (Flu/Mel; 52%; P = .53), and Flu/Mel + anti-thymocyte globulin (ATG; 44%; P = .38

2018 Blood advances

15. Darbepoetin alfa (Aranesp) for treatment of anaemia in adults with low or intermediate-1-risk myelodysplastic syndromes

technologies. This search will not return all technologies currently in development as these outputs are produced as required for our stakeholders. > > > Darbepoetin alfa (Aranesp) for treatment of anaemia in adults with low or intermediate-1-risk myelodysplastic syndromes Darbepoetin alfa (Aranesp) for treatment of anaemia in adults with low or intermediate-1-risk myelodysplastic syndromes August 2017 Myelodysplastic syndromes (MDS) are a group of blood disorders, in which the bone marrow does not produce (...) Darbepoetin alfa (Aranesp) for treatment of anaemia in adults with low or intermediate-1-risk myelodysplastic syndromes Darbepoetin alfa (Aranesp) for treatment of anaemia in adults with low or intermediate-1-risk myelodysplastic syndromes | Innovation Observatory toggle menu Menu Search View All Filter by Speciality Filter by Year Filter by Category This search function provides links to outputs produced by NIHR Innovation Observatory. These are briefing notes or reports on new or repurposed

2017 NIHR Innovation Observatory

16. Allogeneic hematopoietic stem cell transplantation for Crohn disease complicated with myelodysplastic syndrome: A case report. Full Text available with Trip Pro

Allogeneic hematopoietic stem cell transplantation for Crohn disease complicated with myelodysplastic syndrome: A case report. Myelodysplastic syndrome (MDS) can be complicated with Crohn disease (CD). Irritable bowel disease (IBD) associated with MDS has already been reported in the past; however, hematopoietic stem cell transplantation (HSCT) is rarely performed. Herein, we report a case of CD with MDS for HSCT.A 41-year-old man was hospitalized due to abdominal pain and intermittent fever

2020 Medicine

17. Impact of the number of mutations in survival and response outcomes to hypomethylating agents in patients with myelodysplastic syndromes or myelodysplastic/myeloproliferative neoplasms Full Text available with Trip Pro

Impact of the number of mutations in survival and response outcomes to hypomethylating agents in patients with myelodysplastic syndromes or myelodysplastic/myeloproliferative neoplasms The prognostic and predictive value of sequencing analysis in myelodysplastic syndromes (MDS) has not been fully integrated into clinical practice. We performed whole exome sequencing (WES) of bone marrow samples from 83 patients with MDS and 31 with MDS/MPN identifying 218 driver mutations in 31 genes in 98 (86

2018 Oncotarget

18. Evaluation of induction chemotherapies after hypomethylating agent failure in myelodysplastic syndromes and acute myeloid leukemia Full Text available with Trip Pro

Evaluation of induction chemotherapies after hypomethylating agent failure in myelodysplastic syndromes and acute myeloid leukemia Hypomethylating agent (HMA) failure in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) carries a poor prognosis with limited treatment options. Although intensive, remission induction chemotherapy is often used subsequently, in particular to bridge to allogeneic transplantation, it is not clear whether an advantage exists for any particular regimen (...) %, OS 6 months, and 42% of responding patients bridged to allo-SCT. Prognostic factors for response in MDS included adverse cytogenetics (odds ratio [OR], 0.46, P = .01), age ≥65 years (OR, 0.47; P < .01), and use of IDAC (OR, 2.91, P = .01). Shorter survival was associated with adverse cytogenetics (hazard ratio [HR], 1.43; P = .06). In the AML cohort, OS was decreased by disease progression at time of HMA failure (HR, 2.66; P = .02) and prolonged with use of an anthracycline-containing regimen (HR

2018 Blood advances

19. Early platelet count kinetics has prognostic value in lower-risk myelodysplastic syndromes Full Text available with Trip Pro

Early platelet count kinetics has prognostic value in lower-risk myelodysplastic syndromes Prognosis of lower-risk (International Prognostic Scoring System [IPSS] low/intermediate-1) myelodysplastic syndrome (MDS) is heterogeneous and relies on steady-state assessment of cytopenias. We analyzed relative drops in neutrophil and platelet counts during the first 6 months of follow-up of lower-risk MDS patients. We performed a landmark analysis of overall survival (OS) of lower-risk MDS patients

2018 Blood advances

20. Molecular pathophysiology of the myelodysplastic syndromes: insights for targeted therapy Full Text available with Trip Pro

Molecular pathophysiology of the myelodysplastic syndromes: insights for targeted therapy The clinical heterogeneity of the myelodysplastic syndromes (MDSs) relates to the recently discerned panoply of molecular abnormalities extant within this disease spectrum. Despite increasing recognition of these biologic abnormalities, very limited therapeutic options exist to exploit our increasing understanding of the molecular pathophysiology of MDS, with only 1 therapy (lenalidomide) particularly (...) focused on a specific clinical patient subset (del(5q) cytogenetics) and 2 epigenetic modulators (azacitidine and decitabine) having been approved for treating these patients. This article will review the mutational and biologic landscape of these disorders, as well as the targeted therapeutics currently in clinical trials that are focused on attacking these features. Given the molecular complexity of these disorders and the limited repertoire of effective therapeutic agents, we will also discuss

2018 Blood advances

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