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https://www.readbyqxmd.com/read/29734213/clinical-and-radiographic-response-of-extramedullary-leukemia-in-patients-treated-with-gemtuzumab-ozogamicin
#1
Michael J McNeil, Marguerite T Parisi, Nobuko Hijiya, Soheil Meshinchi, Todd Cooper, Katherine Tarlock
Extramedullary leukemia (EML) is common in pediatric acute leukemia and can present at diagnosis or relapse. CD33 is detected on the surface of myeloid blasts in many patients with acute myelogenous leukemia and is the target of the antibody drug conjugate gemtuzumab ozogamicin (GO). Here we present 2 patients with CD33 EML treated with GO. They achieved significant response, with reduction of EML on both clinical and radiographic exams, specifically fluorine fluorodeoxyglucose positron emission tomography/computed tomography, demonstrating potential for targeted therapy with GO as a means of treating EML in patients with CD33 leukemia and the utility of fluorine fluorodeoxyglucose positron emission tomography/computed tomography monitoring in EML...
May 4, 2018: Journal of Pediatric Hematology/oncology
https://www.readbyqxmd.com/read/29713444/personalizing-initial-therapy-in-acute-myeloid-leukemia-incorporating-novel-agents-into-clinical-practice
#2
REVIEW
Christin B DeStefano, Christopher S Hourigan
While the past decade has seen a revolution in understanding of the genetic and molecular etiology of the disease, in clinical practice, initial therapy for acute myeloid leukemia (AML) patients has been a relatively straightforward choice between intensive combination cytotoxic induction therapy as used for decades or less-intensive hypomethylating therapy. The year 2017, however, witnessed US Food and Drug Administration approvals of midostaurin, enasidenib, gemtuzumab ozogamicin and CPX-351 for AML patients, with many other promising agents currently in clinical trials...
May 2018: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/29680875/salvage-regimens-using-conventional-chemotherapy-agents-for-relapsed-refractory-adult-aml-patients-a-systematic-literature-review
#3
REVIEW
Juan Eduardo Megías-Vericat, David Martínez-Cuadrón, Miguel Ángel Sanz, Pau Montesinos
Prognosis in relapsed and refractory acute myeloid leukemia (R/R AML) patients is dismal, with no satisfactory and standard salvage chemotherapy regimen. We performed a systematic review in order to analyze the clinical outcomes reported with conventional chemotherapy schemes in adult patients with R/R AML. To have a better understanding of the R/R ground, we included studies in R/R AML adult population at any disease stage (i.e., primary refractory as well as first relapse or beyond). Study selection included a total number of 157 out of 850 records, with a wide variety of schedules...
April 21, 2018: Annals of Hematology
https://www.readbyqxmd.com/read/29650683/fda-approval-summary-mylotarg-for-treatment-of-patients-with-relapsed-or-refractory-cd33-positive-acute-myeloid-leukemia
#4
Kelly J Norsworthy, Chia-Wen Ko, Jee Eun Lee, Jiang Liu, Christy S John, Donna Przepiorka, Ann T Farrell, Richard Pazdur
On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older. GO is a CD33-directed antibody drug conjugate linked to the cytotoxic antibiotic calicheamicin. It originally received accelerated approval for treatment of older patients with relapsed CD33-positive AML in 2000, but it was withdrawn from the market in 2010 when the confirmatory trial failed to demonstrate clinical benefit among safety concerns, such as a higher rate of induction fatalities on the GO combination arm compared with chemotherapy alone...
April 12, 2018: Oncologist
https://www.readbyqxmd.com/read/29588393/imgn779-a-novel-cd33-targeting-antibody-drug-conjugate-with-dna-alkylating-activity-exhibits-potent-antitumor-activity-in-models-of-aml
#5
Yelena Kovtun, Paul Noordhuis, Kathleen R Whiteman, Krystal Watkins, Gregory E Jones, Lauren Harvey, Katharine C Lai, Scott Portwood, Sharlene Adams, Callum M Sloss, Gerrit Jan Schuurhuis, Gert Ossenkoppele, Eunice S Wang, Jan Pinkas
The myeloid differentiation antigen CD33 has long been exploited as a target for antibody-based therapeutic approaches in acute myeloid leukemia (AML). Validation of this strategy was provided with the approval of the CD33-targeting antibody-drug conjugate (ADC) gemtuzumab ozogamicin in 2000; the clinical utility of this agent has however been hampered by safety concerns. Thus, the full potential of CD33-directed therapy in AML remains to be realized, and considerable interest exists in the design and development of more effective ADCs that confer high therapeutic indices and favorable tolerability profiles...
March 27, 2018: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/29572158/a-phase-i-ii-trial-of-the-combination-of-azacitidine-and-gemtuzumab-ozogamicin-for-treatment-of-relapsed-acute-myeloid-leukemia
#6
Bruno C Medeiros, Tiffany N Tanaka, Larisa Balaian, Asad Bashey, Amy Guzdar, Hongying Li, Karen Messer, Edward D Ball
INTRODUCTION: Treatment with hypomethylating agent therapy might enhance anti-CD33 monoclonal antibody-mediated cytotoxicity against acute myeloid leukemia (AML) blasts through epigenetic effects on Syk and SHP-1 expression. PATIENTS AND METHODS: In the present phase I/II study, we treated patients with relapsed or refractory AML with azacitidine, followed by 2 doses of gemtuzumab ozogamicin (GO) at 6 mg/m2 , the Food and Drug Administration-approved dose and schedule at study initiation...
March 2, 2018: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29572070/escmid-study-group-for-infections-in-compromised-hosts-esgich-consensus-document-on-the-safety-of-targeted-and-biological-therapies-an-infectious-diseases-perspective-agents-targeting-lymphoid-or-myeloid-cells-surface-antigens-ii-cd22-cd30-cd33-cd38-cd40-slamf
#7
REVIEW
Lubos Drgona, Carlota Gudiol, Simone Lanini, Bernd Salzberger, Giuseppe Ippolito, Małgorzata Mikulska
BACKGROUND: The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies. AIMS: To review, from an Infectious Diseases perspective, the safety profile of agents targeting CD22, CD30, CD33, CD38, CD40, SLAMF-7 and CCR4 and to suggest preventive recommendations. SOURCES: Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family...
March 20, 2018: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29534618/investigational-cd33-targeted-therapeutics-for-acute-myeloid-leukemia
#8
REVIEW
Roland B Walter
There is long-standing interest in drugs targeting the myeloid differentiation antigen CD33 in acute myeloid leukemia (AML). Positive results from randomized trials with the antibody-drug conjugate (ADC) gemtuzumab ozogamicin (GO) validate this approach. Partly stimulated by the success of GO, several CD33-targeted therapeutics are currently in early phase testing. Areas covered: CD33-targeted therapeutics in clinical development include Fc-engineered unconjugated antibodies (BI 836858 [mAb 33.1]), ADCs (SGN-CD33A [vadastuximab talirine], IMGN779), radioimmunoconjugates (225 Ac-lintuzumab), bi- and trispecific antibodies (AMG 330, AMG 673, AMV564, 161533 TriKE fusion protein), and chimeric antigen receptor (CAR)-modified immune effector cells...
April 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29476018/fda-approval-gemtuzumab-ozogamicin-for-the-treatment-of-adults-with-newly-diagnosed-cd33-positive-acute-myeloid-leukemia
#9
Emily Y Jen, Chia-Wen Ko, Jee Eun Lee, Pedro L Del Valle, Antonina Aydanian, Charles Jewell, Kelly J Norsworthy, Donna Przepiorka, Lei Nie, Jiang Liu, Christopher M Sheth, Marjorie Shapiro, Ann T Farrell, Richard Pazdur
On September 1, 2017, FDA granted approval for gemtuzumab ozogamicin (GO) (Mylotarg; Pfizer, Inc) in combination with daunorubicin and cytarabine (DA) and as a monotherapy for the treatment of adult patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). GO is a CD33-targeted antibody-drug conjugate joined to calicheamicin. Approval of GO combination treatment was based on a randomized trial of 271 patients with newly-diagnosed AML treated with DA with or without 3 mg/m2 fractionated GO, which resulted in an event-free survival (EFS) of 13...
February 23, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29396857/flai-fludarabine-cytarabine-idarubicin-plus-low-dose-gemtuzumab-ozogamicin-as-induction-therapy-in-cd33-positive-aml-final-results-and-long-term-outcome-of-a-phase-ii-multicenter-clinical-trial
#10
Anna Candoni, Cristina Papayannidis, Giovanni Martinelli, Erica Simeone, Michele Gottardi, Ilaria Iacobucci, Filippo Gherlinzoni, Giuseppe Visani, Michele Baccarani, Renato Fanin
The aim of this prospective clinical trial was to evaluate the efficacy and safety of a combination of Gemtuzumab-Ozogamicin (GO) and FLAI scheme (fludarabine, cytarabine, idarubicin) as a first-line therapy in CD33 positive AML. We treated 130 patients, aged <65, with a median age of 52 years. FLAI-GO induction regimen included fludarabine (30 mg/sqm) and cytarabine (2 g/sqm) on days 1-5; idarubicin (10 mg/sqm) on days 1, 3, and 5; and GO (3 mg/sqm) on day 6. SCT was planned for all high-risk AML patients, after consolidation with intermediate doses of cytarabine and idarubicin and a high dose of cytarabine...
May 2018: American Journal of Hematology
https://www.readbyqxmd.com/read/29296877/the-role-of-targeted-therapy-in-the-management-of-patients-with-aml
#11
REVIEW
Alexander E Perl
Drug therapy for acute myeloid leukemia (AML) is finally undergoing major changes in 2017. This is due to the US Food and Drug Administration's approval of several new, targeted agents (midostaurin, enasidenib, and gemtuzumab ozogamicin). Paired with the recent approval of a novel liposomal formulation of daunorubicin/cytarabine (CPX-351/Vyxeos), the standard of care is changing rapidly in AML for subgroups. This review will focus on currently approved agents and promising novel agents in development and will highlight controversial areas in targeted treatment...
November 14, 2017: Blood Advances
https://www.readbyqxmd.com/read/29283906/new-therapeutic-strategies-for-high-risk-acute-myeloid-leukemia
#12
Kamal Menghrajani, Martin S Tallman
PURPOSE OF REVIEW: Treatments for acute myeloid leukemia (AML) had remained essentially unchanged for several years; however, the advent of molecular testing has generated insight into the biology of this disease which is now being translated into clinical practice. New treatment strategies which improve drug delivery and exploit cellular targets are changing the landscape of how we treat this disease. RECENT FINDINGS: Induction therapy is in the process of changing for several patient populations...
March 2018: Current Opinion in Hematology
https://www.readbyqxmd.com/read/29240026/gemtuzumab-ozogamicin-containing-chemotherapy-for-relapsed-or-refractory-acute-myeloid-leukemia-aml-in-children
#13
Anthony Pak-Yin Liu, Alex Wing-Kwan Leung, Daniel Ka-Leung Cheuk, Vincent Lee, Shau-Yin Ha
No abstract text is available yet for this article.
March 2018: Journal of Pediatric Hematology/oncology
https://www.readbyqxmd.com/read/29222237/the-role-of-targeted-therapy-in-the-management-of-patients-with-aml
#14
REVIEW
Alexander E Perl
Drug therapy for acute myeloid leukemia (AML) is finally undergoing major changes in 2017. This is due to the US Food and Drug Administration's approval of several new, targeted agents (midostaurin, enasidenib, and gemtuzumab ozogamicin). Paired with the recent approval of a novel liposomal formulation of daunorubicin/cytarabine (CPX-351/Vyxeos), the standard of care is changing rapidly in AML for subgroups. This review will focus on currently approved agents and promising novel agents in development and will highlight controversial areas in targeted treatment...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29206680/immune-therapies-in-acute-myeloid-leukemia-a-focus-on-monoclonal-antibodies-and-immune-checkpoint-inhibitors
#15
Rita Assi, Hagop Kantarjian, Farhad Ravandi, Naval Daver
PURPOSE OF REVIEW: This review discusses the rationale, efficacy, and toxicity of a variety of immune approaches being evaluated in the therapy of acute myeloid leukemia (AML) including naked and conjugated monoclonal antibodies, bispecific T-cell engager antibodies, and immune checkpoint blockade via antibodies targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed-death 1 (PD-1). RECENT FINDINGS: The stellar success of immune therapies that harness the power of T cells in solid tumors and an improved understanding of the immune system in patients with hematologic malignancies have resulted in major efforts to develop immune therapies for the treatment of patients with AML...
March 2018: Current Opinion in Hematology
https://www.readbyqxmd.com/read/29188435/antibody-drug-conjugates-pharmacokinetic-pharmacodynamic-modeling-preclinical-characterization-clinical-studies-and-lessons-learned
#16
REVIEW
William D Hedrich, Tamer E Fandy, Hossam M Ashour, Hongbing Wang, Hazem E Hassan
Antibody-drug conjugates are an emerging class of biopharmaceuticals changing the landscape of targeted chemotherapy. These conjugates combine the target specificity of monoclonal antibodies with the anti-cancer activity of small-molecule therapeutics. Several antibody-drug conjugates have received approval for the treatment of various types of cancer including gemtuzumab ozogamicin (Mylotarg® ), brentuximab vedotin (Adcetris® ), trastuzumab emtansine (Kadcyla® ), and inotuzumab ozogamicin, which recently received approval (Besponsa® )...
November 29, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29176353/new-developments-in-immunotherapy-for-pediatric-leukemia
#17
Jessica B Foster, Shannon L Maude
PURPOSE OF REVIEW: Immunotherapy for the treatment of cancer has advanced at a tremendous pace over the last decade. In this review, we provide an overview of recent progress in immunotherapy for the treatment of leukemia, focusing on antibody-drug conjugates (ADC), bi-specific T-cell engagers (BiTE), and chimeric antigen receptor (CAR) T cells. RECENT FINDINGS: Ongoing clinical trials of CAR T cells directed against CD19 have produced complete remission rates as high as 93%, prompting global multicenter phase 2 trials and the first FDA approval of a CAR T-cell therapy...
February 2018: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/29172076/gemtuzumab-ozogamicin-go-inclusion-to-induction-chemotherapy-eliminates-leukemic-initiating-cells-and-significantly-improves-survival-in-mouse-models-of-acute-myeloid-leukemia
#18
Cathy C Zhang, Zhengming Yan, Bernadette Pascual, Amy Jackson-Fisher, Donghui Stephen Huang, Qing Zong, Mark Elliott, Conglin Fan, Nanni Huser, Joseph Lee, Matthew Sung, Puja Sapra
Gemtuzumab ozogamicin (GO) is an anti-CD33 antibody-drug conjugate for the treatment of acute myeloid leukemia (AML). Although GO shows a narrow therapeutic window in early clinical studies, recent reports detailing a modified dosing regimen of GO can be safely combined with induction chemotherapy, and the combination provides significant survival benefits in AML patients. Here we tested whether the survival benefits seen with the combination arise from the enhanced reduction of chemoresidual disease and leukemic initiating cells (LICs)...
January 2018: Neoplasia: An International Journal for Oncology Research
https://www.readbyqxmd.com/read/29156201/which-new-agents-will-be-incorporated-into-frontline-therapy-in-acute-myeloid-leukemia
#19
REVIEW
Richard M Stone
For 4 decades, new agents had not been permanently approved for use in treating acute myeloid leukemia (AML). The long dry spell was broken in 2017, however, with the approval of several agents: midostaurin for addition to chemotherapy in mutant FLT3 patients undergoing intensive chemotherapy, enasidenib in advanced mutant IDH2 patients, CPX-351 in secondary AML patients, and gemtuzumab ozogamicin in conjunction with standard chemotherapy in AML. This review surveys the use of tyrosine kinase inhibitors to treat patients with mutant FLT3 AML, mutant KIT AML, as well as IDH inhibitors and explores some questions regarding their integration into the treatment armamentarium for AML...
December 2017: Best Practice & Research. Clinical Haematology
https://www.readbyqxmd.com/read/29156199/how-can-one-optimize-induction-therapy-in-aml
#20
REVIEW
Selina M Luger
Induction therapy for acute myeloid leukemia has not changed much since 1973, when the 7 + 3 regimen of cytarabine and daunorubicin was born. Since then, various strategies have been evaluated to improve patient response, including dose intensification, the incorporation of additional agents into the regimen, the development of novel agents, and modified approaches for older patients. Recently, two novel agents, CPX-351 and gemtuzumab ozogamicin, have been approved by the US Food and Drug Administration. This review discusses each of the induction strategies and their impact on patient outcomes...
December 2017: Best Practice & Research. Clinical Haematology
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