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Showing 1 - 22FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
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...
FDA Pipeline: Designations for Myelodysplastic Syndromes, Triple-Negative Breast Cancer, AML, and EBV-Associated Cancers
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...
FDA Pipeline: Designation in Uveal Melanoma, Application for MDS Side-Effect Management
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...
FDA Pipeline: Mammography Policies, Designations for Leukemias and Myelodysplastic Syndrome
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...
Combination Azacitidine and Lenalidomide as Salvage Therapy for Relapsed AML After Allogeneic Stem Cell Transplantation
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...
Study Finds Elevated Risk of MDS and AML After Chemotherapy for Most Solid Tumors
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. ...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
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...
Reduced-Intensity vs Standard Conditioning Followed by ASCT in Myelodysplastic Syndrome
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...
Prognostic Scoring System for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndrome
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...
No Significant Survival Advantage for Rigosertib in High-Risk Myelodysplastic Syndromes, but Subgroups May Benefit
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...
Nationally Recognized Leader in Myeloid Malignancies, Alan F. List, MD, Has High Hopes for the Future of Oncology
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...
Self-Reported Fatigue Provides Independent Prognostic Information in Patients With Myelodysplastic Syndromes
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...
Study Explores Link Between Allele Expression and Risk of Graft-vs-Host Disease in Transplant Recipients
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...
ASH 2014: Combination Therapy Shown to Be Effective for Patients With Myelodysplastic Syndrome and AML
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...
TP53, TET2, and DNMT3A Mutations Predict Poorer Survival After Hematopoietic Stem Cell Transplant in Patients With Myelodysplastic Syndrome
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 Thiopurines Associated With Increased Risk of Myeloid Disorders in Patients With Inflammatory Bowel Disease
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...
Prolonged Administration of Azacitidine Improves Response in Myelodysplasia, Less So in Combination With Entinostat
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...
No Apparent Increased Risk of Myelodysplastic Syndrome With Definitive Radiotherapy in Prostate Cancer
Exposure to ionizing radiation has been associated with increased risk of myelodysplastic syndrome, and it remains unclear whether radiation doses used in prostate cancer treatment result in increased risk. In a retrospective cohort study reported in the Journal of the National Cancer Institute,...
Revised International Prognostic Scoring System for MDS Is Better at Predicting Survival than Older Systems
A retrospective analysis of 380 patients with myelodysplastic syndrome (MDS) registered in the Gruppo Romano Mielodisplasie Italian Regional database, which included data from 13 hematology centers in the Rome area, has found that the Revised International Prognostic Scoring System (IPSS-R) is...
Targeting Errant Immune System Enzyme Kills Myelodysplastic Cells
Scientists have successfully targeted a malfunctioning immune system enzyme to kill diseased cells from patients with myelodysplastic syndrome (MDS), a precursor to acute myeloid leukemia (AML). Reporting their results in Cancer Cell, researchers say their successful laboratory tests in human MDS...
Study Sets Guidelines for Stem Cell Transplants in Older Patients with Myelodysplastic Syndromes
A new study by an international team of scientists provides the first statistically based guidelines for determining whether a stem cell transplant is appropriate for older patients with myelodysplastic syndromes (MDS), the most common blood disorders in people over 60 years of age, and frequently...
Moffitt Cancer Center Researchers Study Use of Dasatinib for Patients with High-risk MDS
Researchers at Moffitt Cancer Center have completed a phase II clinical trial to determine the safety and efficacy of dasatinib (Sprycel) for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia, or acute myeloid leukemia resulting from MDS and have failed ...
