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Nina Shah, MD: How Long Should Initial Treatment for Myeloma Last?
Nina Shah, MD, of the University of California, San Francisco, discusses the debate on fixed duration vs waiting until disease progression, a key question for clinicians treating patients with multiple myeloma.
FDA Approves Daratumumab Combination for Transplant-Eligible Patients With Multiple Myeloma
On September 26, 2019, the U.S. Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Efficacy was investigated ...
Benefit of Daratumumab Across Populations With Newly Diagnosed Multiple Myeloma
This week, we review a presentation on the benefit of daratumumab across populations with newly diagnosed multiple myeloma. We also talk about a study on racial disparities in colorectal cancer mortality. Lastly, we discuss the U.S. Food and Drug Administration’s recent approval of apalutamide in...
CMS Expands Coverage of CAR T-Cell Therapy for Medicare Beneficiaries
The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor T-cell (CAR T-cell) therapy for certain patients with cancer. As outlined in ...
Investigating the Inflammatory Mechanisms That May Be Causing Prostate Cancer in World Trade Center First Responders
The terrorist attacks on September 11, 2001*, on the World Trade Center in New York City resulted in the deaths of more than 2,700 people.1 Nearly 2 decades later, that number may soon be exceeded by the more than 2,000 deaths—and climbing—of first responders to the attack, including firefighters,...
Tailoring Upfront Daratumumab Treatment for Some Patients With Multiple Myeloma
The monoclonal antibody daratumumab has been widely embraced for the treatment of multiple myeloma, but for newly diagnosed patients, its benefit has been proved only in some patients, according to Craig Hofmeister, MD, MPH, Associate Professor of Medicine at the Winship Cancer Institute of Emory...
SOHO 2019: Melflufen for Patients With Late-Stage, Relapsed or Refractory Multiple Myeloma Refractory to Daratumumab and/or Pomalidomide
In a presentation of updated efficacy and safety data from the phase II HORIZON trial, Paul G. Richardson, MD, and colleagues found that melflufen, a lipophilic peptide-conjugated alkylator, showed activity in patients with late-stage relapsed or refractory multiple myeloma refractory to...
Benefits Reported With Addition of Isatuximab to Pomalidomide and Dexamethasone in Resistant Multiple Myeloma
In patients with relapsed or refractory multiple myeloma, isatuximab in combination with pomalidomide and low-dose dexamethasone nearly doubled progression-free survival when compared with pomalidomide and dexamethasone alone, with a manageable safety profile, according to data from a phase III...
FDA Pipeline: Breakthrough Therapy Designation in Lung Cancer, Orphan Drug Designations in Myeloma and Soft-Tissue Sarcoma
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tepotinib for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations, and Orphan Drug designations to novel chimeric antigen receptor T-cell therapies in both multiple myeloma ...
Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10
On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...
Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
SITC Publishes First Clinical Immunotherapy Guidelines for Treatment of Head/Neck Squamous Cell Carcinoma
The Society for Immunotherapy of Cancer (SITC) has published the first clinical immunotherapy guidelines for squamous cell carcinoma of the head and neck, providing oncologists and other advanced practice providers with a clinical roadmap to treating this disease with immunotherapies approved in...
Light Intervention for Cancer-Related Fatigue, Depression, and Sleep Disturbance
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. Cancer and its treatments are associated with severe fatigue, depression, ...
Is It Time to Intervene in Smoldering Myeloma?
Early intervention in smoldering multiple myeloma prevents progression to symptomatic disease and should be strongly considered for patients meeting new criteria for high risk, according to Sagar Lonial, MD, Professor and Chair of Hematology and Medical Oncology and the Anne and Bernard Gray...
Risks of Cardiovascular Diseases in Survivors of Adult Cancers
In a study reported in The Lancet, Strongman et al found that survivors of most site-specific cancers had an increased risk for one or more cardiovascular diseases during follow-up compared with a matched control group of patients without cancer. This population-based cohort study employed multiple ...
Selinexor/Dexamethasone in Triple-Class Refractory Multiple Myeloma
In the phase IIb STORM Part 2 study reported in The New England Journal of Medicine, Chari et al found that the combination of oral selinexor and dexamethasone produced responses in patients with multiple myeloma refractory to prior treatment with an alkylating agent, immunomodulatory agent, and...
Selinexor in Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel hematology and 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 July 3, 2019, the oral nuclear export...
Exploratory Analysis Shows DNA Methylation Assay Highly Specific for Cancer Detection
A cell-free DNA test based on the presence of DNA methylation has proven highly specific as a multicancer detection test and appears especially good at detecting high-risk malignancies. In most cases, it can also accurately pinpoint the tumor’s tissue of origin, researchers reported at the 2019...
MMRF Launches CureCloud to Advance Precision Medicine
The Multiple Myeloma Research Foundation (MMRF) announced recently that it is launching the MMRF CureCloud, a centralized data hub that generates, aggregates, and visualizes data to accelerate the delivery of precision medicine to patients with multiple myeloma. The CureCloud is a critical part of...
Pembrolizumab for Advanced Merkel Cell Carcinoma
Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known...
Pembrolizumab in Metastatic Small Cell Lung Cancer
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Notable Presentations at ASCO 2019 Included Studies in Sarcoma, Lymphoma, Myeloma, and Breast and Kidney Cancers
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
On June 27, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received...
Stratification Tool to Predict VTE in Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
New research published by Li et al in JNCCN–Journal of the National Comprehensive Cancer Network has identified a way to help clinicians caring for patients with multiple myeloma to predict blood clots in order to take preventive action. The researchers established a set of risk factors to...
FDA Pipeline: Designations and Applications Granted in Lymphoma, Small Cell Lung Cancer, Multiple Myeloma, and More
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a phospholipid-drug conjugate in diffuse large B-cell lymphoma; granted Orphan Drug designation to an immunotherapy for small cell lung cancer (SCLC); accepted supplemental biologics license applications (sBLAs) ...
Effect of Bortezomib/Dexamethasone Plus Pomalidomide on Progression-Free Survival in Multiple Myeloma Pretreated With Lenalidomide
In the phase III OPTIMISMM trial, reported by Paul G. Richardson, MD, and colleagues in The Lancet Oncology, researchers found that the addition of pomalidomide to bortezomib/dexamethasone improved progression-free survival in relapsed or refractory multiple myeloma previously treated with...
How Immunologic Dysregulation in the Multiple Myeloma Microenvironment May Affect Response to CAR T-Cell Therapy
Despite an avalanche of novel therapies approved by the U.S. Food and Drug Administration (FDA) over the past decade in the treatment of multiple myeloma, including proteasome inhibitors and immunomodulatory drugs, this blood cancer remains largely incurable, and nearly 13,000 people are expected...
Role of Liquid Biopsy in Lymphoma
In this episode, The ASCO Post's Editor-in-Chief Dr. James Armitage talks about the International Conference on Malignant Lymphoma (ICML), which he attended recently in Lugano, Switzerland; in particular, Dr. Armitage shares insight from a workshop on bridging liquid biopsy into the management of...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two...
FDA Pipeline: Applications Accepted in Gynecologic Cancers, Targeted Therapies
Recently, the U.S. Food and Drug Administration (FDA) accepted a new drug application for niraparib in the treatment of certain pretreated gynecologic cancers; granted Fast Track designation to a T-cell product; accepted investigational new drug applications for a myelopreservation agent and an...
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...
CASSIOPEIA Trial in Multiple Myeloma
In this episode, we discuss news from the Annual Congress of the European Hematology Association in multiple myeloma, catch up on a study presented at ASCO on gastric cancer, and review a recently published paper on prostate cancer development in World Trade Center first responders.
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
Accelerated Approval Program: For the Benefit of Patients
A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening,...
Exposure to Specific Carcinogens and Prostate Cancer Risk Among World Trade Center First Responders
Since the attacks on the World Trade Center on September 11, 2001, studies have shown an increased risk of several cancers—including multiple myeloma and prostate, head and neck, and thyroid cancers—among first responders to the scene. The results from a new study by Gong et al...
Are Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma Common?
In a study reported in the Journal of Clinical Oncology, Cornell et al found that cardiovascular adverse events are common in patients receiving proteasome inhibitor therapy for relapsed multiple myeloma and are associated with poorer outcome. The prospective observational study involved 95...
EHA 2019: BELLINI Trial Evaluates Addition of Venetoclax to Bortezomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma
The phase III BELLINI trial—reported by Kumar et al at the 24th Annual Congress of the European Hematology Association (EHA; Abstract LB2601) investigated the efficacy and safety of venetoclax/bortezomib/dexamethasone vs bortezomib/dexamethasone in patients with relapsed or refractory...
EHA 2019: CASSIOPEIA Trial Examines Addition of Daratumumab to Standard Treatment Before and After ASCT in Multiple Myeloma
In the phase III CASSIOPEIA trial, reported in The Lancet and presented at the 24th Annual Congress of the European Hematology Association (EHA; Abstract S145) by Moreau et al, daratumumab plus bortezomib/thalidomide/dexamethasone (D-VTd) given before and after autologous stem cell transplantation...
MAIA Trial: Addition of Daratumumab to Lenalidomide/Dexamethasone in Untreated Myeloma Ineligible for ASCT
In the phase III MAIA trial reported in The New England Journal of Medicine, Facon et al found that the addition of daratumumab to lenalidomide/dexamethasone significantly improved progression-free survival in previously untreated multiple myeloma ineligible for autologous stem cell transplantation ...
Cytogenetic Prognostic Index for Survival in Multiple Myeloma
In a study reported in the Journal of Clinical Oncology, Perrot et al identified a cytogenetic prognostic index predictive of survival in patients with newly diagnosed multiple myeloma. Study Details The study involved data from 1,635 patients in four trials conducted by the Intergroupe...
Dana-Farber Opens Center for the Prevention of Progression for Precursor Hematologic Conditions
Against the backdrop of the online crowd-sourcing initiative PCROWD and other research by faculty investigators on precursor conditions that may develop into leukemia, myelodysplastic syndromes (MDS), or multiple myeloma, Dana-Farber Cancer Institute has opened the Center for the Prevention of...
Selected Abstracts From the 2019 ASCO Annual Meeting
To complement The ASCO Post’s comprehensive coverage of the 2019 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for plasma cell dyscrasias, particularly multiple myeloma. For full details of these study abstracts, visit ...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Selected Studies From the 2019 ASCO Annual Meeting
In this debut episode of The ASCO Post Podcast, experts in breast, prostate, and lung cancers and multiple myeloma provide clinical insights about selected studies presented at the recent ASCO Annual Meeting, plus news from the FDA.
ACA Increases Access to Health Care, Early Diagnosis, and Timely Treatment for Patients With Cancer
The evidence is in: the Affordable Care Act (ACA) has enabled improved access to earlier diagnosis, earlier care, and reduced racial disparities in access to care for patients with cancer, according to two studies presented at the 2019 ASCO Annual Meeting. In states that adopted Medicaid...
Sagar Lonial, MD, on Smoldering Multiple Myeloma: Delaying Disease Progression With an Immunomodulatory Agent
Sagar Lonial, MD, of Winship Cancer Institute of Emory University, discusses the potentially practice-changing phase III findings showing that lenalidomide substantially delayed progression of smoldering multiple myeloma to aggressive disease when compared with observation alone (Abstract 8001).
Michael A. Thompson, MD, PhD, on Smoldering Multiple Myeloma: Reassessing Risk Stratification Models
Michael A. Thompson, MD, PhD, of Advocate Aurora Health, discusses the implications of the revised diagnostic criteria for multiple myeloma, which removed patients at the highest risk of disease progression from the smoldering group, and a new model for smoldering disease that incorporates revised...
Francesca Gay, MD, on Multiple Myeloma: Carfilzomib/Lenalidomide/Dexamethasone With or Without Transplantation
Francesca Gay, MD, of GIMEMA, European Myeloma Network, discusses the results of the FORTE trial on the efficacy of carfilzomib/lenalidomide/dexamethasone with or without autologous stem cell transplantation according to risk status in newly diagnosed disease (Abstract 8002).
