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Showing 51 - 100FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...
FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria
On December 21, 2018, the U.S. Food and Drug Administration (FDA) approved ravulizumab-cwvz (Ultomiris) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare bone marrow failure disorder that manifests with hemolytic anemia, thrombosis, and peripheral blood cytopenias....
FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm
On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...
Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE
Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by...
ASH 2018: Machine Learning–Based Model to Risk Stratify Patients With Myelodysplastic Syndromes
Researchers used machine learning to develop a new system to analyze genomic and clinical data to provide a personalized overall outcome that is patient-specific in myelodysplastic syndromes. In tests, the system outperformed the current standard prognostic tool, suggesting the new model may offer...
ASH 2018: MEDALIST: Luspatercept in Patients With Myelodysplastic Syndrome Requiring Red Blood Cell Transfusion
In the phase III MEDALIST clinical trial, luspatercept significantly reduced the need for frequent blood transfusions in just over half (53%) of patients with myelodysplastic syndromes (MDS) who were anemic, required regular red blood cell transfusions, and showed abnormal iron overload in red...
ASH 2018: Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa
The largest prospective trial of hydroxyurea for sickle cell anemia (SCA) has shown that this treatment—long the standard of care for treating SCA in developed countries—is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Tshilolo et al reported...
New Report Demonstrates Cost of Blood Cancer Care
The costs to treat blood cancer are higher than costs for other cancers, and the costs incurred by a patient diagnosed with a blood cancer do not return to precancer levels, according to a Milliman study commissioned by The Leukemia & Lymphoma Society (LLS). The study—The...
Adoptive T-Cell Therapy for Progressive Multifocal Leukoencephalopathy
An emerging treatment known as adoptive T-cell therapy has proven effective in a phase II clinical trial for treating progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection sometimes observed in patients with cancer and other diseases in which the immune...
Frederick L. Locke, MD, on CAR T-Cell Therapy: Major Milestones
Frederick L. Locke, MD, of Moffitt Cancer Center, discusses the key studies behind the development of CAR T cells, major adverse events and management strategies, and the potential of this revolutionary treatment.
FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy
The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera
A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...
2018 ASCO: iNNOVATE Trial Evaluates Ibrutinib in Combination With Rituximab in Patients With Waldenström's Macroglobulinemia
Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...
Meletios A. Dimopoulos, MD, on Waldenström’s Macroglobulinemia
Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).
Update Regarding Tazemetostat Clinical Program
On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...
FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients
On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...
Clinical Hold Lifted on U.S. Studies of BPX-501
On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...
AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells
Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...
Cognitive Decline Prevalent Among Elderly Patients With Hematologic Cancers
A sizable percentage of elderly patients with blood-related cancers such as leukemia and multiple myeloma are apt to show signs of diminished cognitive functioning—a decline that may impact their survival—a new study by investigators at Dana-Farber Cancer Institute and Brigham and...
Clinical Hold on BPX-501 Trials in the United States Announced
On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed...
Stephen M. Ansell, MD, PhD, on Hematologic Malignancies: Immunotherapy Update
Stephen M. Ansell, MD, PhD, of the Mayo Clinic, discusses integrating immune checkpoint inhibitors, improving efficacy, and reducing toxicity when treating blood cancers.
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura
In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Alok A. Khorana, MD, on The Costs of VTE in Cancer Patients: Expert Perspective
Alok A. Khorana, MD, of the Cleveland Clinic, discusses the prevalence of venous thromboembolism in cancer patients treated at U. S. emergency departments and associated costs, mortality, and hospital admissions in the United States (Abstract 219).
ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis
In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...
Watch for More From ASH 2017
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer
People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
Ruben A. Mesa, MD, on Myeloproliferative Neoplasms: Managing PV and ET
Ruben A. Mesa, MD, of The University of Texas Health San Antonio Cancer Center, discusses the role of JAK2 inhibitors in treating polycythemia vera and essential thrombocythemia and how to develop individualized therapy based on risk stratification.
Early-Phase Study Finds Vitamin C May Activate TET2 Function
Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published by Cimmino et al in Cell....
Clonal Hematopoiesis in Patients With Nonhematologic Cancers
In a study of nearly 9,000 people treated for solid tumors, researchers found that radiation treatment and tobacco use were linked to higher rates of blood-based DNA mutations that could lead to a higher risk for blood cancers such as leukemia. The study, published by Coombs et al in...
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...
FDA Approves Betrixaban for the Prophylaxis of Venous Thromboembolism
On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility...
ASCO 2017: Ibrutinib Plus Cellular Therapy CTL119 May Lead to Complete Remissions in CLL
Combining the kinase inhibitor ibrutinib (Imbruvica) with an investigational personalized cellular therapy known as CTL119 can lead to complete remission in patients with high-risk chronic lymphocytic leukemia (CLL), according to new research from the Perelman School of Medicine at the University...
David H. Henry, MD, and Ruben A. Mesa, MD, on Myelofibrosis: Trial Results From a Best of ASCO Abstract
David H. Henry, MD, of Pennsylvania Oncology Hematology Associates, and Ruben A. Mesa, MD, of the Mayo Clinic Cancer Center, discuss phase III study findings on momelotinib vs ruxolitinib in JAK inhibitor–naive patients with myelofibrosis. (Abstract 7000)
Lack of Access to Transfusions Limits Hospice Use by Patients With Blood Cancer
A new survey finds that doctors would refer more patients with incurable blood cancers to hospice for end-of-life care if they could receive transfusions, which are generally not available because of hospice reimbursement policies. The findings, published by Odejide et al in Cancer, help explain...
FDA Approves Midostaurin in Combination With Chemotherapy for Newly Diagnosed FLT3-Positive Acute Myeloid Leukemia
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test, in combination with standard cytarabine and...
FDA Removes Risk Evaluation and Mitigation Strategy Requirements for Erythropoiesis-Stimulating Agents
On April 13, the U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) requirements for the use of epoetin alfa and darbepoetin alfa to treat patients with anemia due to associated myelosuppressive chemotherapy. The Agency's announcement regarding...
FDA Grants Marketing Authorization for Ipsogen JAK2 RGQ PCR Kit to Detect JAK2 Genetic Mutations
The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH, to detect mutations affecting the Janus tyrosine kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating...
AACR 2017: IDH-Mutant Cancers May Be More Amenable to Treatment With PARP Inhibitors Than IDH Inhibitors, According to Preclinical Findings
Tumors with mutations in the proteins isocitrate dehydrogenase-1 or -2 (IDH1/2) exhibited features similar to BRCA-mutant tumors and were more likely to respond better to PARP inhibitors than to IDH inhibitors, according to preclinical data presented by Sulkowski et al at the 2017 American...
Ruben A. Mesa, MD, on Myeloproliferative Neoplasms and Myelofibrosis: New Treatment Guidelines 126
Ruben A. Mesa, MD, of the Mayo Clinic Cancer Center, discusses molecular abnormalities and their use in the diagnosis, risk stratification, and selection of treatment for myelofibrosis.
Early Biomarker Algorithm May Predict Graft-vs-Host Disease Occurrence
Researchers at Mount Sinai Health System have discovered a way to predict whether patients with blood cancer who received a bone marrow transplant will develop graft-vs-host disease, according to a study published by Hartwell et al in JCI (The Journal of Clinical...
Effect of Inpatient Palliative Care on Quality of Life After Stem Cell Transplant
Integrating palliative care into the treatment of patients undergoing hematopoietic stem cell transplantation for cancers like leukemia and lymphoma can improve their quality of life, relieve symptoms associated with the procedure, and reduce depression and anxiety, not only during the 3- to 4-week ...
ASH 2016: New Data Shed Light on Potential Advantages of Pacritinib for Patients With Myelofibrosis
Compared with standard therapy, pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, according to a late-breaking study presented by Mascarenhas et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition...
ASH 2016: Ibrutinib Found Helpful in Treating Graft-vs-Host Disease After Stem Cell Transplant
A late-breaking abstract presented by Miklos et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-3) showed patients who experience graft-vs-host disease (GVHD) after stem cell transplantation that is not resolved by corticosteroid...
