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Showing 751 - 800FDA Pipeline: Safety Warning About Investigational Use of Venetoclax in Multiple Myeloma, Warning Letter on Unapproved Products
This week, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma, and also posted a warning letter against a company for illegally marketing unapproved products labeled as homeopathic. Safety Statement The FDA posted...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
Reshaping the Treatment Landscape in Refractory Multiple Myeloma
THE TREATMENT approaches for multiple myeloma, both newly diagnosed and relapsed disease, continue to undergo major transformation as new agents and combinations are being introduced.1 This change has been driven by the introduction of novel drug classes such as monoclonal antibodies, as well as...
Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Patients With Multiple Myeloma
AS REPORTED in The New England Journal of Medicine by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab to pomalidomide and dexamethasone significantly prolonged...
Advances in Haploidentical Transplantation and Cellular Therapies
With advances in the field, the number of haploidentical stem cell transplants being performed (ie, using human leukocyte antigen [HLA] half-matched donor stem cells) has been increasing. In recognition of evolving strategies to improve outcomes, a group of transplant physicians started the...
Perlmutter Cancer Center Receives Anonymous $75 Million Gift to Create Center for Blood Cancers
NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center recently announced a philanthropic gift to establish a Center for Blood Cancers. The center will house a new program for multiple myeloma care and research, along with NYU Langone Health’s other blood cancer programs. It will also...
Conference Highlights From the 2018 American Society of Hematology Annual Meeting & Exposition
In sunny San Diego, the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition welcomed nearly 30,000 attendees who were eager to present, learn, network, and cheer the joint achievements of many researchers. The packed meeting was filled with important information from...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 30, 2018, pembrolizumab in combination with...
FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma
ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed...
Highlights From the 2018 ASH Annual Meeting & Exposition
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...
Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD
In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...
Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma: Outcomes From the MAIA Trial
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...
Cancer Has Given Me the Life I Was Meant to Live
The first symptom of my multiple myeloma appeared 6 months before I received the official diagnosis. I began having some discomfort, not pain exactly, in my right hip, and developed a pronounced limp. I had recently left my medical practice to launch Global Girls Global Women, a nonprofit...
FDA Approves Daratumumab Split-Dosing Regimen
The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...
FDA Pipeline: Treatments for Tenosynovial Giant Cell Tumor and Pancreatic Cancer, Plus a Statement on Breast Implant–Associated Lymphoma
The U.S. Food and Drug Administration (FDA) recently granted the following designations and applications and also issued a statement: Priority Review for Pexidartinib in Tenosynovial Giant Cell Tumor The FDA has accepted a new drug application (NDA) and granted Priority Review for pexidartinib...
Obesity-Related Cancers Rising in Young Adults in the United States
A new study has found rates are increasing for 6 of 12 cancers related to obesity in younger adults in the United States, with steeper increases in progressively younger ages and successively younger generations. The study, published by Sung et al in The Lancet Public Health, also looked at rates...
Expert Point of View: Ravi Vij, MD and Saad Usmani, MD
Ravi Vij, MD, Professor of Medicine at Washington University School of Medicine, St. Louis, and Saad Usmani, MD, Director of Plasma Cell Disorders at Levine Cancer Institute, Charlotte, North Carolina, spoke to The ASCO Post about the studies presented on chimeric antigen receptor (CAR) T-cell...
Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies
The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...
Trial of Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma
In a phase III trial reported in the Journal of Clinical Oncology, Stadtmauer and colleagues found that second autologous hematopoietic cell transplantation (AHCT) or RVD (lenalidomide, bortezomib, dexamethasone) consolidation as post-AHCT interventions did not improve outcomes vs single...
Hastening the Development of Novel Therapies for Peripheral T-Cell Lymphomas
Peripheral T-cell lymphomas (PTCLs) make up a small fraction of all non-Hodgkin lymphomas—just 15%—in the United States.1 Although rare in the United States, the incidence of PTCL is common across Asia, the Caribbean, and sub-Saharan Africa. Although the reason for such global variation in PTCL is...
MMRF Launches First Platform Trial in Multiple Myeloma
THE MULTIPLE MYELOMA Research Foundation (MMRF) has announced the launch of MyDRUG, the first platform trial exclusively in multiple myeloma, which aims to investigate targeted treatments for patients with high-risk myeloma. MyDRUG represents the culmination of the MMRF’s Precision Medicine Model,...
ASH Research Collaborative Established to Accelerate Progress in Hematology
THE AMERICAN SOCIETY of Hematology (ASH) has established the ASH Research Collaborative, a mission-focused nonprofit organization that will foster collaborative partnerships to accelerate progress in hematology with the goal of improving the lives of people affected by blood diseases. “The launch...
Novel Therapeutics for Relapsed or Refractory Multiple Myeloma, Part 2
Here is an update on several different studies focusing on novel treatments for patients with relapsed or refractory multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. The featured therapeutics include the oral agent selinexor in...
Novel Treatments in Newly Diagnosed Multiple Myeloma, Part 1
Here is an update on several different studies focusing on novel treatments for patients with newly diagnosed multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Featured therapeutics include daratumumab plus lenalidomide and dexamethasone, ...
Analysis of Proportion of Cancer Cases Attributable to Excess Body Weight Across U.S. States
In a study reported in JAMA Oncology, Islami et al assessed the population attributable fraction (PAF)—the proportion of a given outcome attributable to a given risk factor—of incident cancer cases associated with excess body weight among individual U.S. states during 2011 to 2015. The...
Incidence of Acute Kidney Injury in Patients Receiving Systemic Therapy for Cancer
In a Canadian population–based cohort study reported in the Journal of the National Cancer Institute, Kitchlu et al found that acute kidney injury (AKI) is common in patients receiving systemic therapy for newly diagnosed cancer and has increased in incidence in recent years. Study Details...
Association Between Systemic Lupus Erythematosus and Cancer Risk
New research published by Song et al in Arthritis Research & Therapy evaluated the link between lupus and cancer risk, supporting the data from earlier studies. The newer study indicates an association between systemic lupus erythematosus (SLE) and increased risk for several cancers (blood,...
Lenalidomide Maintenance vs Observation in Newly Diagnosed Multiple Myeloma
In a UK phase III trial (Myeloma XI) reported in The Lancet Oncology, Jackson et al found that lenalidomide maintenance was associated with improved progression-free survival but not overall survival among patients with newly diagnosed multiple myeloma with at least minimal response to induction...
I Welcome Being the Face of Multiple Myeloma
Thirteen years ago, at age 34, I was healthy and enjoying life. I went to the gym almost daily, and when I wasn’t at the gym, I was shooting hoops with my friends. During a gym workout while on a family vacation, I suddenly felt excruciating pain in my left shoulder and thought I must have strained ...
Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD
In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
Shaji K. Kumar, MD, on Newly Diagnosed Multiple Myeloma: Treatment Trial Results
Shaji K. Kumar, MD, of the Mayo Clinic, discusses phase III findings on daratumumab plus lenalidomide and dexamethasone vs lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who are ineligible for transplant (Abstract LBA2).
ASH 2018: MAIA Trial: Does Adding Daratumumab Improve Outcomes in Patients With Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplant?
Interim results from a large international phase III clinical trial show that adding the immunotherapy daratumumab (Darzalex) to standard therapy significantly extended progression-free survival (PFS) in newly diagnosed patients with multiple myeloma who were ineligible for a stem cell transplant....
Paul Richardson, MD, on Multiple Myeloma: Results From the OP-106 Horizon Trial
Paul Richardson, MD, of Dana-Farber Cancer Institute, discusses updated results and the first report on progression-free survival for melflufen therapy administered to people with multiple myeloma that is refractory to daratumumab and/or pomalidomide (Abstract 600).
Francesca M. Gay, MD, on Multiple Myeloma: Results From the Forte Trial
Francesca M. Gay, MD, of GIMEMA, European Myeloma Network, discusses study findings on the use of carfilzomib in induction combination regimens with autologous transplantation, and consolidation regimens in newly diagnosed multiple myeloma (Abstract 121).
ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma
As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...
ASH Honors Freda K. Stevenson, DPhil, and Brunangelo Falini, MD, With 2018 Henry M. Stratton Medal
THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) will recognize Freda K. Stevenson, DPhil, of the University of Southampton and Southampton University Hospitals in the United Kingdom, and Brunangelo Falini, MD, of the University of Perugia and the Institute of Hematology and Bone Marrow Transplantation...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at...
Duvelisib in Resistant Chronic Lymphocytic Leukemia: Expanding the Treatment Armamentarium
The phase III DUO trial, reported by Flinn et al and reviewed in this issue of The ASCO Post, has led to the U.S. Food and Drug Administration (FDA) approval of a novel B-cell receptor (BCR) kinase inhibitor, duvelisib (Copiktra), which targets phosphoinositide 3-kinase (PI3K)-δ/γ in patients...
Leukemia & Lymphoma Society Receives Funding for New Grants
The Leukemia & Lymphoma Society recently announced a $1,175,000 commitment by the Schwartz Ward Family Foundation of Chicago to support two research initiatives. These funds will support two grants in the society’s Career Development Program: Christiane Querfeld, MD, PhD, of City of Hope, is...
FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
Cancer Care in the U.S. Prison System
A health-care system is evaluated by various metrics: one is how it cares for its most vulnerable patients. The United States spends far more on health care than any nation in the world, yet access to high-quality oncology services remains elusive to certain minority populations—none more so than...
FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA...
Updated ASCO Answers Fact Sheets for Your Practice
Be sure to check out these newly updated ASCO Answers fact sheets: Chronic Lymphocytic Leukemia Lung Cancer Melanoma Multiple Myeloma Pancreatic Cancer Prostate Cancer Thrombocytopenia When Cancer Spreads to the Bone These one-page (front and back) introductions include a topic overview; an...
Emerging Options and Sequencing Therapy in Relapsed Multiple Myeloma
Advances in the treatment of multiple myeloma have led to longer progression-free survival, but the majority of patients will still relapse despite newer treatments. A number of new drugs and combinations are under study in the hope of improving outcomes. “Multiple myeloma is a complex disease...
FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...
Strategies for Using Anticoagulation Therapy in Patients With Cancer
Although approximately 20% to 30% of patients with cancer will develop venous thromboembolism (VTE), clinicians continue to debate strategies for pharmacologic treatment and prevention.1 At the 2018 Debates and Didactics in Hematology and Oncology Conference, held on Sea Island, Georgia, Christine...
