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Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...
Ilaria Iacobucci, PhD, of St. Jude Children’s Research Hospital, discusses her work to more accurately define mutation subtypes in acute myeloid leukemia and myelodysplastic syndromes, as well as the implications for diagnosis, prognosis, and treatment (Abstract LBA-4 ).
Researchers have completed the first comprehensive analysis combining full genomic sequencing and gene-expression profiles of more than 1,300 patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The research was presented by Iacobucci et al during the 2019 American Society...
Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses results of a phase Ib study of glasdegib in combination with azacitidine, which showed activity in patients with untreated myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who are ineligible for intensive chemotherapy (Abstract 177).
Despite the spate of recent drug approvals in blood cancer, it’s been more than 13 years since the U.S. Food and Drug Administration (FDA) has approved a treatment for myelodysplastic syndromes (MDS), a bone marrow disorder characterized by ineffective hematopoiesis. Nevertheless, data from a...
Rafael Bejar, MD, PhD, of the University of California, San Diego Moores Cancer Center, discusses the tailored nature of MDS treatment, including somatic mutations that could alter treatment decisions, and novel therapies with predictive biomarkers.
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
MORE DATA are in to support early intervention for high-risk smoldering multiple myeloma—an early, asymptomatic entity lacking the presence of CRAB criteria (elevated calcium, renal failure, anemia, bone lesions). The latest come from two phase II studies presented at the 2018 American Society of...
PRESS BRIEFING moderator Joseph Mikhael, MD, Professor of Applied Cancer Research and Drug Discovery, Translational Genomics Research Institute, City of Hope Cancer Center in Phoenix, noted that traditional models are based on simplicity, and the scoring system contains few variables. “In an era...
A PERSONALIZED risk-prediction model for myelodysplastic syndromes (MDS) has been developed through the use of a machine-learning approach that analyzes genomic and clinical data for an individual patient. According to lead investigator Aziz Nazha, MD, of the Cleveland Clinic, the model provides...
Over the past week, the U.S. Food and Drug Administration (FDA) granted several Fast Track and Orphan Drug designations to treatments for myelodysplastic syndromes, triple-negative breast cancer, acute myeloid leukemia (AML), and Epstein-Barr virus (EBV)-associated cancers. Fast Track Designation...
Over the past week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for metastatic uveal melanoma and received a biologics application for an agent to control anemia. Fast Track Designation for Tebentafusp in Metastatic Uveal Melanoma The FDA granted...
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on seven different studies on new therapeutics in myelodysplastic syndromes (MDS). Among the treatments highlighted here are the erythroid maturation...
In a phase I trial reported in the Journal of Clinical Oncology, Craddock et al found evidence that the sequential combination of azacitidine and lenalidomide may be an effective salvage therapy in patients with acute myeloid leukemia (AML) relapsing after allogeneic stem cell transplantation...
Findings from a new study by researchers at the National Cancer Institute (NCI) show that patients treated with chemotherapy for most solid tumors from 2000 to 2014 experienced an increased risk of therapy-related myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). The study, which used U.S. ...
Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses phase III study findings on luspatercept to treat anemia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes with ring sideroblasts who require red blood cell transfusions (Abstract 1).
Suleika Jaouad, an Emmy Award–winning writer, advocate, and cancer survivor who was diagnosed at age 22 with myelodysplastic syndrome and acute myeloid leukemia, discusses what she has learned about coping with cancer, learning from it, and growing beyond it.
THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...
Although several treatment options are available for patients with myelodysplastic syndromes (MDS), hematopoietic stem cell transplantation (HSCT) remains the only curative therapy.1 The risks of complications and death from transplantation can be substantial. Determining which patients may...
In a study reported in The New England Journal of Medicine, R. Coleman Lindsley, MD, PhD, of Dana-Farber Cancer Institute, and colleagues found that a number of mutations present in patients with myelodysplastic syndromes (MDS) were associated with poorer clinical outcome after allogeneic...
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
In the phase III RICMAC trial, use of a dose-reduced vs a standard myeloablative conditioning regimen prior to allogeneic stem cell transplantation (ASCT) did not appear to reduce 2-year relapse-free or overall survival in patients with myelodysplastic syndrome. These findings were reported by...
Steven D. Gore, MD, Director of Hematologic Malignancies at Yale School of Medicine, New Haven, Connecticut, applauded Dr. Stein for “accruing a terrible patient population, mutation-wise” and called the preliminary findings for the benefit of enasidenib in patients with ASXL1 mutations...
At the 2016 American Society for Hematology (ASH) Annual Meeting & Exposition, researchers reported early success with two new experimental agents for high-risk myelodysplastic syndromes—enasidenib (also known as AG-221), a potent oral inhibitor of the isocitrate dehydrogenase 2 (IDH2) enzyme,...
As reported in the Journal of Clinical Oncology, Shaffer et al have developed a prognostic scoring system for patients undergoing allogeneic hematopoietic cell transplantation for myelodysplastic syndrome. Study Details The study involved data from 2,133 patients with myelodysplastic syndrome in...
As reported in The Lancet Oncology by Garcia-Manero et al, the phase III ONTIME trial showed that treatment with the Ras mimetic rigosertib did not significantly improve overall survival vs best supportive care in patients with high-risk myelodysplastic syndromes after failure of hypomethylating...
Here are several more abstracts selected from the proceedings of the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition, highlighting therapeutics in acute leukemias and myelodysplastic syndromes. For five other top abstracts on therapies for acute leukemias and myelodysplastic ...
Alan F. List, MD, of Moffitt Cancer Center, offers his thoughts on abstract 3251, “An Open-Label, Phase II, Dose-Finding Study of Sotatercept (ACE-011) in Patients With Low or Intermediate-1–Risk Myelodysplastic Syndromes or Nonproliferative Chronic Myelomonocytic Leukemia and Anemia Requiring Transfusion,” presented by Rami S. Komrokji, MD.
Richard M. Stone, MD, of Dana-Farber Cancer Institute, offers his thoughts on abstract LBA-5, “A Randomized Phase II Study of Azacitidine Combined With Lenalidomide or With Vorinostat vs Azacitidine Monotherapy in Higher-Risk Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia: North American Intergroup Study SWOG S1117,” presented by Mikkael A. Sekeres, MD, MS.
Alan F. List, MD, of Moffitt Cancer Center, offers his thoughts on abstract 409, “Efficacy and Safety of Lenalidomide vs Placebo in RBC Transfusion–Dependent Patients With IPSS Low-/Intermediate-Risk Myelodysplastic Syndromes Without Del(5q) and Unresponsive or Refractory to Erythropoiesis-Stimulating Agents: Results From a Randomized Phase III Study (CC-5013-MDS-005),” presented by Valeria Santini, MD.
Alan F. List, MD, of Moffitt Cancer Center, offers his thoughts on abstract 163, “Overall Survival and Subgroup Analysis From a Randomized Phase III Study of Intravenous Rigosertib vs Best Supportive Care in Patients With Higher-Risk Myelodysplastic Syndrome After Failure of Hypomethylating Agents,” presented by Guillermo Garcia-Manero, MD. Time: 1:54
Alan F. List, MD, of Moffitt Cancer Center and the University of South Florida, and James O. Armitage, MD, FACP, FRCP, of the University of Nebraska Medical Center, discuss the biology and diagnostic criteria for myelodysplastic syndrome, as well as advances in the disease presented at the 56th ASH Annual Meeting.
James O. Armitage, MD, FACP, FRCP, of the University of Nebraska Medical Center, and Richard M. Stone, MD of the Dana-Farber Cancer Institute, discuss three clinical trials: different doses of daunorubicin for AML; comparing azacitidine plus lenolidomide to vorinostat vs azacitidine monotherapy in MDS and CMML; and sorafenib vs placebo in addition to standard treatment for AML.
A randomized trial from the Bone and Marrow Transplant Clinical Trials Network was halted early after concluding that allogeneic stem cell transplantation after a reduced-intensity conditioning regimen resulted in higher relapse rates compared to myeloablative conditioning. The phase III randomized ...
Telik, Inc, announced that its product candidate, ezatiostat hydrochloride (Telintra), has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndromes (MDS). Ezatiostat is an investigational agent in development for the treatment of MDS and idiopathic chronic...
Most recent advances in the management of myelodysplastic syndrome (MDS) are in the area of genetics, according to Steven Gore, MD, of Yale University School of Medicine, New Haven. “New genomics research is leading to a better understanding of MDS heterogeneity and disease biology, and may...
Although the data are preliminary, experts were impressed with responses to a novel IDH2 inhibitor called AG-221 in patients with hematologic malignancies. In the first clinical trial of AG-221, there were three complete remissions, two complete remissions with incomplete platelet count recovery...
The Tampa Bay area of Florida is a haven for golfers and fishermen looking to unwind under the warm tropical skies. And the clean highways stretching through the scenic west coast of Florida are also a perfect excuse for weekend motorcycle enthusiasts, such as Alan F. List, MD, the President and...
Refinements in the classification and risk stratification for leukemia and myelodysplastic syndromes were reported by three different investigators at the 2015 ASCO Annual Meeting. The first study showed that leukemia stem cell phenotypes are associated with outcomes in acute myeloid leukemia...
Here are several abstracts selected from the proceedings of this year’s American Society of Hematology (ASH) Annual Meeting and Exposition, highlighting therapeutics in acute leukemias and myelodysplastic syndromes. For full details of these study abstracts, visit...
Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses an additional analysis of a phase II study of azacitidine combined with lenalidomide or with vorinostat vs azacitidine monotherapy in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia (Abstract 908).
In a prospective observational cohort study reported in The Lancet Oncology, Efficace et al found that a self-reported fatigue score provides independent prognostic information on overall survival in patients with higher-risk myelodysplastic syndromes. Fatigue assessment should be included in...
In a study reported in The New England Journal of Medicine, Petersdorf et al found a greater risk of acute graft-vs-host disease among hematopoietic cell transplant recipients with the high-expression rs9277534G allele linked to mismatched HLA-DPB1 who received transplants from donors with the...
A phase II study investigating the potential of the drugs azacitidine and lenalidomide (Revlimid) demonstrated that the two therapies in combination may be an effective frontline treatment regimen for patients with higher-risk forms of myelodysplastic syndrome and acute myeloid leukemia (AML). The...
It is unclear whether somatic mutations that are strongly associated with phenotype and prognosis in myelodysplastic syndrome are also predictive of outcome after allogeneic hematopoietic stem cell transplantation. In a study reported in the Journal of Clinical Oncology, Bejar et al found that...
Past exposure to immunosuppressive drugs called thiopurines has been found to increase the risk of myeloid disorders, such as acute myeloid leukemia and myelodysplastic syndrome, among patients with inflammatory bowel disease (IBD). The findings were reported by Lopez et al in Clinical...
In the phase II US Leukemia Intergroup Trial E1905 reported in the Journal of Clinical Oncology, Prebet et al found that prolonged administration of lower-dose azacitidine produced a high response rate in patients with myelodysplastic syndrome or acute myeloid leukemia (AML) with myelodysplastic...