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hematologic malignancies

FDA Approves Fedratinib for Myelofibrosis

Today, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic) for adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with...

hematologic malignancies

First-Degree Familial Risk in Blood Cancer Development

New data suggest that people who have a parent, sibling, or child with blood cancer have a higher likelihood of being diagnosed with a hematologic malignancy themselves. A study by Sud et al published in Blood offers the first...

hematologic malignancies
multiple myeloma

IMWG Consensus Recommendations on Imaging in Monoclonal Plasma Disorders

Just as newer drugs have significantly improved outcomes for patients with multiple myeloma in the past decade, newer imaging techniques are upgrading detection of the disease, leading to earlier treatment, but standards to help guide clinicians on the optimal use of advanced imaging have lagged...

hematologic malignancies

Gait Speed Identifies Frailty, Could Help Predict Outcomes in Older Patients With Hematologic Cancers

The speed at which older individuals with blood cancers are able to walk 4 meters (about 13 feet) holds information about their overall health and may help to predict survival and unplanned hospital visits, according to study published by Liu et al in Blood. The association was...

health-care policy
hematologic malignancies
immunotherapy

ASH President Comments on Medicare Proposal for CAR T-Cell Therapy

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor T-cell (CAR-T) therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment...

hematologic malignancies

Racial Disparities in Matched Volunteer Stem Cell Donors

Although the pool of registered bone marrow donors has increased in recent years, a new study suggests that most patients of southern European and non-European descent are unlikely to have a suitable match if they need a bone marrow transplant. If an immediate registry search does not identify a...

hematologic malignancies

Gary H. Lyman, MD, MPH, on Myeloid Growth Factors: New Biosimilar Approvals

Gary H. Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, discusses current strategies for the use of biosimilars to treat cancer-induced anemia and neutropenia, and the need to provide evidence for the efficacy of these agents to allay any concerns about...

breast cancer
gynecologic cancers
hematologic malignancies
leukemia
lymphoma
symptom management

FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More

The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...

hematologic malignancies
symptom management

Letter to the Editor: Survey on DOACs in Cancer-Related Venous Thromboembolism

This letter is a follow-up to a report published previously in The ASCO Post. Recent trials report comparable or improved efficacy of direct-acting oral coagulants (DOACs) over low–molecular-weight heparins (LMWH) in the treatment of cancer-related VTE (cVTE) at the expense of increased...

colorectal cancer
solid tumors
hematologic malignancies
pancreatic cancer
symptom management

FDA 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 ...

hematologic malignancies

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....

hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies
cost of care

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...

hematologic malignancies
immunotherapy

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...

hematologic malignancies
immunotherapy

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.

hematologic malignancies

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 ...

solid tumors
hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies

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...

hematologic malignancies
immunotherapy

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...

hematologic malignancies
immunotherapy

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).

solid tumors
hematologic malignancies

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...

hematologic malignancies

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 ...

hematologic malignancies

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...

solid tumors
hematologic malignancies

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...

hematologic malignancies
symptom management

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...

hematologic malignancies

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...

hematologic malignancies
immunotherapy

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.

hematologic malignancies
symptom management

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...

hematologic malignancies

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...

hematologic malignancies
symptom management

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...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

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...

hematologic malignancies
issues in oncology
cost of care

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).

hematologic malignancies

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 ...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

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...

hematologic malignancies
issues in oncology

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 ...

hematologic malignancies

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...

hematologic malignancies

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 ...

hematologic malignancies

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.

hematologic malignancies
leukemia

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....

solid tumors
hematologic malignancies

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...

hematologic malignancies
leukemia
lymphoma
myelodysplastic syndromes

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...

hematologic malignancies
symptom management

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...

hematologic malignancies

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...

hematologic malignancies

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)

palliative care
hematologic malignancies

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...

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