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https://www.readbyqxmd.com/read/29445113/a-decade-of-progress-in-myelodysplastic-syndrome-with-chromosome-5q-deletion
#1
REVIEW
Alan List, Benjamin L Ebert, Pierre Fenaux
There are few instances in oncology where reciprocal clinical and laboratory translation studies have accelerated the understanding of disease biology and treatment more so than the decade following the Food and Drug Administration (FDA) approval of lenalidomide (Revlimid TM ; Celgene Corporation, Summit, NJ, USA) for the treatment of patients with myelodysplastic syndrome (MDS) and chromosome 5q deletion (del(5q)). Lenalidomide was approved by the FDA in December 2005 on the merits of a multicenter phase 2 study, which demonstrated sustained and prolonged transfusion independence in the majority of participants...
January 30, 2018: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/29396091/ibrutinib-lenalidomide-and-rituximab-in-relapsed-or-refractory-mantle-cell-lymphoma-philemon-a-multicentre-open-label-single-arm-phase-2-trial
#2
Mats Jerkeman, Christian Winther Eskelund, Martin Hutchings, Riikka Räty, Karin Fahl Wader, Anna Laurell, Helle Toldbod, Lone Bredo Pedersen, Carsten Utoft Niemann, Christina Dahl, Hanne Kuitunen, Christian H Geisler, Kirsten Grønbæk, Arne Kolstad
BACKGROUND: Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. METHODS: In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0-3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters...
January 29, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29378690/celgene-targets-blood-cancers-with-major-buys
#3
(no author information available yet)
Celgene acquired Juno Therapeutics for $9 billion and is spending up to $7 billion on Impact Biomedicines in an effort to diversify its hematology portfolio with chimeric antigen receptor T-cell therapies and a JAK2 inhibitor before its best seller, lenalidomide, faces competition from generics.
January 29, 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29331635/sotatercept-with-long-term-extension-for-the-treatment-of-anaemia-in-patients-with-lower-risk-myelodysplastic-syndromes-a-phase-2-dose-ranging-trial
#4
Rami Komrokji, Guillermo Garcia-Manero, Lionel Ades, Thomas Prebet, David P Steensma, Joseph G Jurcic, Mikkael A Sekeres, Jesus Berdeja, Michael R Savona, Odile Beyne-Rauzy, Aspasia Stamatoullas, Amy E DeZern, Jacques Delaunay, Gautam Borthakur, Robert Rifkin, Thomas E Boyd, Abderrhamane Laadem, Bond Vo, Jennie Zhang, Marie Puccio-Pick, Kenneth M Attie, Pierre Fenaux, Alan F List
BACKGROUND: Myelodysplastic syndromes are characterised by ineffective erythropoiesis leading to anaemia. Sotatercept (ACE-011) is a novel activin receptor type IIA fusion protein that acts as a ligand trap to neutralise negative regulators of late-stage erythropoiesis. The aim of the study was to establish a safe and effective dose of sotatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes. METHODS: This open-label, multicentre, dose-ranging, phase 2 trial took place at 11 treatment centres in the USA and France...
January 10, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/28958469/lenalidomide-maintenance-therapy-in-previously-treated-chronic-lymphocytic-leukaemia-continuum-a-randomised-double-blind-placebo-controlled-phase-3-trial
#5
Asher A Chanan-Khan, Andrey Zaritskey, Miklos Egyed, Samuel Vokurka, Sergey Semochkin, Anna Schuh, Jeannine Kassis, David Simpson, Jennie Zhang, Brendan Purse, Robin Foà
BACKGROUND: The efficacy and safety of lenalidomide as maintenance therapy after chemotherapy-based second-line therapy in patients with chronic lymphocytic leukaemia is unknown. Although kinase inhibitors can improve outcomes for some patients with relapsed and refractory disease, not all patients have access to these novel drugs. In this study, we aimed to assess the efficacy and safety of lenalidomide as maintenance therapy in patients with previously treated chronic lymphocytic leukaemia...
November 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28944728/performance-based-risk-sharing-arrangements-u-s-payer-experience
#6
Joseph A Goble, Brian Ung, Sascha van Boemmel-Wegmann, Robert P Navarro, Andrew Parece
BACKGROUND: As a result of global concern about rising drug costs, many U.S. payers and European agencies such as the National Health Service have partnered with pharmaceutical companies in performance-based risk-sharing arrangements (PBRSAs) by which manufacturers share financial risk with health care purchasing entities and authorities. However, PBRSAs present many administrative and legal challenges that have minimized successful contract experiences in the United States. OBJECTIVE: To (a) identify drug and disease characteristics and contract components that contribute to successful PBRSA experiences and the primary barriers to PBRSA execution and (b) explore solutions to facilitate contract negotiation and execution...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28916311/lenalidomide-maintenance-after-first-line-therapy-for-high-risk-chronic-lymphocytic-leukaemia-cllm1-final-results-from-a-randomised-double-blind-phase-3-study
#7
Anna Maria Fink, Jasmin Bahlo, Sandra Robrecht, Othman Al-Sawaf, Ali Aldaoud, Holger Hebart, Kathleen Jentsch-Ullrich, Steffen Dörfel, Kirsten Fischer, Clemens-Martin Wendtner, Thomas Nösslinger, Paolo Ghia, Francesc Bosch, Arnon P Kater, Hartmut Döhner, Michael Kneba, Karl-Anton Kreuzer, Eugen Tausch, Stephan Stilgenbauer, Matthias Ritgen, Sebastian Böttcher, Barbara Eichhorst, Michael Hallek
BACKGROUND: The combined use of genetic markers and detectable minimal residual disease identifies patients with chronic lymphocytic leukaemia with poor outcome after first-line chemoimmunotherapy. We aimed to assess lenalidomide maintenance therapy in these high-risk patients. METHODS: In this randomised, double-blind, phase 3 study (CLLM1; CLL Maintenance 1 of the German CLL Study Group), patients older than 18 years and diagnosed with immunophenotypically confirmed chronic lymphocytic leukaemia with active disease, who responded to chemoimmunotherapy 2-5 months after completion of first-line therapy and who were assessed as having a high risk for an early progression with at least a partial response after four or more cycles of first-line chemoimmunotherapy, were eligible if they had high minimal residual disease levels or intermediate levels combined with an unmutated IGHV gene status or TP53 alterations...
October 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28879540/enasidenib-first-global-approval
#8
Esther S Kim
Enasidenib (Idhifa®) is an oral isocitrate dehydrogenase-2 (IDH2) inhibitor developed by Celgene Corporation under a global, exclusive license from Agios Pharmaceuticals. Enasidenib has been approved in the USA for the treatment of adults with relapsed or refractory acute myeloid leukaemia (AML) and an IDH2 mutation as detected by an FDA-approved test. It is at various stages of development in other countries for AML, myelodysplastic syndromes and solid tumours. This article summarizes the milestones in the development of enasidenib leading to this first global approval in the USA for the treatment of adults with relapsed or refractory IDH2-mutated AML...
October 2017: Drugs
https://www.readbyqxmd.com/read/28680953/the-cost-impact-of-lenalidomide-for-newly-diagnosed-multiple-myeloma-in-the-eu5
#9
Steve Schey, Luis Felipe Casado Montero, Chloe Stengel-Tosetti, Craig J Gibson, Sujith Dhanasiri
INTRODUCTION: Lenalidomide is an active agent that was approved for use in the EU in 2015 as a first-line therapy for previously untreated, non-transplant eligible multiple myeloma patients. Our objective was to assess the cost impact of lenalidomide when selected as a first-line treatment for transplant-ineligible patients in France, Germany, Italy, Spain, and the United Kingdom (EU5). METHODS: We developed a cost-impact model of the total costs associated with newly diagnosed multiple myeloma over 5 years in the EU5 based on treatment duration and time to progression (TTP) (taken from trial data)...
2017: Oncology and Therapy
https://www.readbyqxmd.com/read/28468739/a-phase-iii-study-of-lenalidomide-maintenance-after-debulking-therapy-in-patients-with-advanced-cutaneous-t-cell-lymphoma-eortc-21081-nct01098656-results-and-lessons-learned-for-future-trial-designs
#10
Martine Bagot, Baktiar Hasan, Sean Whittaker, Marie Beylot-Barry, Robert Knobler, Emad Shah, Sandrine Marreaud, Stephen Morris, Stephane Dalle, Octavio Servitje, Richard Cowan, Liisa Väkevä, Guillaume Chaby, Constanze Jonak, Christopher P Fox, Diana Ritchie, Maarten H Vermeer, Rudolf Stadler, Pablo L Ortiz Romero, Julia Scarisbrick, Pietro Quaglino
EORTC 21081 was a randomized phase III study of observation alone versus lenalidomide maintenance (25 mg po for 21 days) after debulking therapy in patients with advanced-stage cutaneous T-cell lymphomas (CTCLs). The aim was to investigate whether maintenance treatment with lenalidomide prolonged response after debulking in patients who had not been previously treated with intravenous chemotherapy. A total of 26 centres from 10 different European countries registered 30 patients with advanced CTCL. Twenty-one patients were randomized (20% of the 105 patients initially deemed necessary for the study; the study was terminated early following withdrawal of funding support from Celgene)...
May 3, 2017: European Journal of Dermatology: EJD
https://www.readbyqxmd.com/read/28452243/evaluation-of-us-2016-0115161-a1-isoindoline-compounds-and-methods-of-their-use
#11
Rok Frlan, Stanislav Gobec
Immunomodulatory drugs (IMIDs®) are small orally available molecules that modulate the immune system and other biological targets through multiple mechanisms of action and have been successfully used in the treatment of myelodysplastic syndrome and multiple myeloma. However, recent studies of their complex mechanism of action revealed their potential in autoimmune diseases and solid tumors, which intensified scientific interest in these compounds. Areas covered: This patent application claims new IMIDs for the treatment of cancer and disorders associated with angiogenesis and inflammation...
June 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#12
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#13
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28397697/nab-paclitaxel-plus-either-gemcitabine-or-simplified-leucovorin-and-fluorouracil-as-first-line-therapy-for-metastatic-pancreatic-adenocarcinoma-afugem-gercor-a-non-comparative-multicentre-open-label-randomised-phase-2-trial
#14
Jean-Baptiste Bachet, Pascal Hammel, Jérôme Desramé, Aurélia Meurisse, Benoist Chibaudel, Thierry André, Philippe Debourdeau, Jérome Dauba, Thierry Lecomte, Jean-François Seitz, Christophe Tournigand, Thomas Aparicio, Véronique Guerin Meyer, Julien Taieb, Julien Volet, Amandine Monier, Franck Bonnetain, Christophe Louvet
BACKGROUND: Nab-paclitaxel plus gemcitabine has become a standard treatment regimen in patients with metastatic pancreatic adenocarcinoma; however, retrospective data suggest that gemcitabine might be inefficient in 50-60% of patients and thus not an optimum regimen in combination with nab-paclitaxel. We did a phase 2 trial to assess the activity and safety of a new regimen of nab-paclitaxel plus simplified leucovorin and fluorouracil. METHODS: We did a non-comparative, multicentre, open-label, randomised phase 2 trial in 15 hospitals and institutions in France...
May 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28379796/lenalidomide-bortezomib-and-dexamethasone-with-transplantation-for-myeloma
#15
RANDOMIZED CONTROLLED TRIAL
Michel Attal, Valerie Lauwers-Cances, Cyrille Hulin, Xavier Leleu, Denis Caillot, Martine Escoffre, Bertrand Arnulf, Margaret Macro, Karim Belhadj, Laurent Garderet, Murielle Roussel, Catherine Payen, Claire Mathiot, Jean P Fermand, Nathalie Meuleman, Sandrine Rollet, Michelle E Maglio, Andrea A Zeytoonjian, Edie A Weller, Nikhil Munshi, Kenneth C Anderson, Paul G Richardson, Thierry Facon, Hervé Avet-Loiseau, Jean-Luc Harousseau, Philippe Moreau
BACKGROUND: High-dose chemotherapy plus autologous stem-cell transplantation has been the standard treatment for newly diagnosed multiple myeloma in adults up to 65 years of age. However, promising data on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone (RVD) in this population have raised questions about the role and timing of transplantation. METHODS: We randomly assigned 700 patients with multiple myeloma to receive induction therapy with three cycles of RVD and then consolidation therapy with either five additional cycles of RVD (350 patients) or high-dose melphalan plus stem-cell transplantation followed by two additional cycles of RVD (350 patients)...
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28378713/the-preparation-characterization-structure-and-dissolution-analysis-of-apremilast-solvatomorphs
#16
Yun Deng Wu, Xiao Lei Zhang, Xiao Hong Liu, Jian Xu, Mei Zhang, Kun Shen, Si Han Zhang, Yong Mei He, Yan Ma, Ai Hua Zhang
Apremilast (AP) {systematic name: (S)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-4-acetamidoisoindoline-1,3-dione} is an inhibitor of phosphodieasterase-4 (PDE4) and is indicated for the treatment of adult patients with active psoriatic arthritis. The ability of AP to form solvates has been investigated and three solvatomorphs of AP, namely, the AP ethyl acetate hemisolvate, C22H24N2O7S·0.5C4H8O2, the AP toluene hemisolvate, C22H24N2O7S·0.5C7H8, and the AP dichloromethane monosolvate, C22H24N2O7S·CH2Cl2, were obtained...
April 1, 2017: Acta Crystallographica. Section C, Structural Chemistry
https://www.readbyqxmd.com/read/28267723/celgene-eyes-inverse-vaccines-in-anokion-and-delinia-deals
#17
Cormac Sheridan
No abstract text is available yet for this article.
March 7, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#18
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28219694/lenalidomide-maintenance-in-patients-with-relapsed-diffuse-large-b-cell-lymphoma-who-are-not-eligible-for-autologous-stem-cell-transplantation-an-open-label-single-arm-multicentre-phase-2-trial
#19
Andrés J M Ferreri, Marianna Sassone, Francesco Zaja, Alessandro Re, Michele Spina, Alice Di Rocco, Alberto Fabbri, Caterina Stelitano, Maurizio Frezzato, Chiara Rusconi, Renato Zambello, Suzana Couto, Yan Ren, Annalisa Arcari, Giovanni Bertoldero, Alessandro Nonis, Lydia Scarfò, Teresa Calimeri, Caterina Cecchetti, Marianna Chiozzotto, Silvia Govi, Maurilio Ponzoni
BACKGROUND: Patients with relapsed diffuse large B-cell lymphoma (DLBCL) not eligible for autologous stem cell transplantation (ASCT) or having relapse after ASCT have a low likelihood of cure. Single-drug maintenance after salvage therapy might be an attractive strategy to prolong survival in these patients. Lenalidomide is a suitable candidate for long-lasting maintenance as it is an oral drug, active against DLBCL that can be taken for years with an acceptable toxicity profile. We designed a study to investigate safety and efficacy of lenalidomide maintenance in patients with chemosensitive relapse of DLBCL not eligible for ASCT or having relapse after ASCT...
February 16, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28125374/the-value-of-survival-gains-in-pancreatic-cancer-from-novel-treatment-regimens
#20
Joanna P MacEwan, Wes Yin, Satyin Kaura, Zeba M Khan
BACKGROUND: Metastatic pancreatic cancer (mPC) is associated with low survival, with less than 10% of patients surviving 5 years. Recent therapies improve survival outcomes where few alternative therapies exist, but few economic analyses measure the value of survival gains attributable to new therapies. OBJECTIVE: To estimate the value of survival gains in advanced or mPC attributable to the introduction of novel treatment regimens. METHODS: Multivariate Cox proportional hazards models were used to estimate real-world survival gains associated with the introduction of gemcitabine (GEM) for patients diagnosed with stage IV or unstaged mPC in the Surveillance, Epidemiology, and End Results Program cancer registries...
February 2017: Journal of Managed Care & Specialty Pharmacy
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