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Lung Cancer
Multiple Myeloma
Sarcoma

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 ...

Immunotherapy
Multiple Myeloma

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...

Multiple Myeloma

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...

Multiple Myeloma

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...

Multiple Myeloma

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...

Breast Cancer
Kidney Cancer
Sarcoma
Lymphoma
Multiple Myeloma

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...

Multiple Myeloma

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 ...

Hematologic Malignancies
Multiple Myeloma

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...

multiple myeloma

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...

gynecologic cancer
lung cancer
lymphoma
skin cancer
multiple myeloma

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) ...

Multiple Myeloma

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...

Multiple Myeloma
Immunotherapy

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...

multiple myeloma

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...

solid tumors
gynecologic cancer
lymphoma
multiple myeloma

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...

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...

multiple myeloma
immunotherapy

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 ...

multiple myeloma

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...

multiple myeloma

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...

multiple myeloma
immunotherapy

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...

multiple myeloma
immunotherapy

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 ...

multiple myeloma

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...

lymphoma
multiple myeloma
prostate cancer
immunotherapy

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...

multiple myeloma

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).

multiple myeloma

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 cutoffs for the previously used parameters (Abstract 8000).

multiple myeloma

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).  

multiple myeloma
immunotherapy

Paul G. Richardson, MD, on Relapsed or Refractory Multiple Myeloma: Adding Isatuximab to Pomalidomide and Low-Dose Dexamethasone

Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses findings from the phase III ICARIA-MM trial showing that isatuximab, pomalidomide, and low-dose dexamethasone significantly improved progression-free survival and overall response vs pomalidomide and dexamethasone (Abstract 8004).  

multiple myeloma
issues in oncology

Kamal Chamoun, MD, on Multiple Myeloma: Insurance Status and Survival

Kamal Chamoun, MD, of University Hospitals Seidman Cancer Center, discusses how better insurance coverage determines not only the ability of patients with multiple myeloma to afford high-priced oral medications, but their survival of the disease (Abstract LBA107).

multiple myeloma
issues in oncology

2019 ASCO: Does Insurance Status Impact Survival in Patients With Multiple Myeloma?

A new study analyzing demographic statistics from the National Cancer Database presented by Chamoun et al at the 2019 ASCO Annual Meeting (Abstract LBA107) identified multiple socioeconomic factors—including private insurance, living in a regionally higher-income area, and receiving treatment ...

multiple myeloma

OPTIMISMM: Addition of Pomalidomide to Bortezomib/Dexamethasone in Pretreated Relapsed or Refractory Multiple Myeloma

In the phase III OPTIMISMM trial, reported by Richardson et al 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 lenalidomide. Study Details...

cns cancers
solid tumors
leukemia
multiple myeloma
sarcoma

FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes

This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...

multiple myeloma

2019 ASCO: Lenalidomide May Reduce the Risk of Smoldering Multiple Myeloma Progressing to Active Disease

A phase III randomized trial (E3A06) by Lonial et al testing the effect of single-agent lenalidomide vs observation in patients with intermediate- or high-risk smoldering multiple myeloma has found that lenalidomide significantly reduces the risk of smoldering multiple myeloma progressing to active ...

multiple myeloma
immunotherapy

Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma

In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...

multiple myeloma

DNA Rearrangement May Predict Treatment Resistance and Poor Outcomes in Multiple Myeloma

A certain type of DNA marker may predict poor outcomes in multiple myeloma, researchers at Winship Cancer Institute of Emory University have found. The marker is a particular rearrangement of chromosomes that is rarely tested for but may indicate resistance to immunomodulatory drugs such as...

Multiple Myeloma

Expert Point of View: High-Risk Smoldering Multiple Myeloma

IN SPITE of the high response rates and lack of progression to active disease with the regimens described at the 2018 American Society of Hematology Meeting & Exposition, several myeloma experts interviewed by The ASCO Post said the data do not yet move them to routinely intervene in high-risk...

Multiple Myeloma

Robert A. Kyle, MD, Luminary in Myeloma Research: Journey From a One-Room Schoolhouse to Groundbreaking Research

In this installment of Living a Full Life, guest editor Jame Abraham, MD, FACP, interviewed multiple myeloma pioneer Robert A. Kyle, MD, whose groundbreaking work has changed the practice of hematology. Among his many honors are the David A. Karnofsky Memorial Award from ASCO and the Wallace H....

multiple myeloma

Patient-Reported Outcomes With Salvage Autologous Stem Cell Transplantation vs Nontransplantation in Relapsed Multiple Myeloma

In an analysis of the phase III UK Myeloma X trial reported in the Journal of Clinical Oncology, Ahmedzai et al found that patient-reported outcomes tended to be worse with salvage autologous stem cell transplantation (ASCT) vs nontransplantation consolidation in relapsed multiple myeloma. The...

Hematologic Malignancies
Multiple Myeloma

FDA Warning: Investigational Use of Venetoclax in Multiple Myeloma

On March 21, 2019, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma. The statement alerts health-care professionals and patients about the suspension of the BELLINI trial (ClinicalTrials.gov identifier NCT02755597) of ...

cns cancers
leukemia
multiple myeloma

FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML

This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...

Multiple Myeloma

Expert Point of View: Kenneth Shain, MD, PhD

KENNETH SHAIN, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, told The ASCO Post that ixazomib is “an effective drug,” but he is not ready to use it as maintenance therapy. He noted that the TOURMALINE-MM3 trial did meet its primary endpoint—but not...

Multiple Myeloma

Maintenance Ixazomib Delays Disease Progression in Newly Diagnosed Myeloma

IN PATIENTS with newly diagnosed multiple myeloma who responded well to induction therapy and underwent transplant, 2 years of maintenance therapy with ixazomib led to a 38% improvement in progression-free survival compared with placebo, according to the results of the phase III TOURMALINE-MM3...

Multiple Myeloma
Immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...

Immunotherapy
Multiple Myeloma

ASH Reports Show Benefit of Adding Daratumumab to Initial Therapy in Multiple Myeloma

DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...

multiple myeloma
pain management

FDA 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...

breast cancer
leukemia
multiple myeloma
issues in oncology

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...

Multiple Myeloma

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...

Multiple Myeloma

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...

Multiple Myeloma

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...

Leukemia
Myelodysplastic Syndromes
Lymphoma
Multiple Myeloma
Immunotherapy

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...

Hematologic Malignancies
Multiple Myeloma

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...

Hematologic Malignancies
Multiple Myeloma

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...

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