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gynecologic cancers
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

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 cancers
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...

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

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...

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
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
immunotherapy

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...

multiple myeloma

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...

multiple myeloma

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...

breast cancer
solid tumors
leukemia
lung cancer
lymphoma
multiple myeloma
issues in oncology
immunotherapy

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...

multiple myeloma

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....

multiple myeloma

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).

multiple myeloma

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).

multiple myeloma

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...

multiple myeloma

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,...

multiple myeloma

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...

leukemia
multiple myeloma

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...

multiple myeloma

FDA Approves Once-Weekly Carfilzomib in Combination With Dexamethasone for Relapsed or Refractory Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to expand the prescribing information for carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or...

multiple myeloma

Shaji K. Kumar, MD, on Multiple Myeloma: Treatment Update

Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses emerging therapeutic options for relapsed multiple myeloma and how best to sequence treatments.

multiple myeloma

Natalie S. Callander, MD, on Newly Diagnosed Multiple Myeloma: Expert Perspective

Natalie S. Callander, MD, of the University of Wisconsin Carbone Cancer Center, discusses key patient and clinical factors that influence first-line treatment choices, as well as the efficacy and tolerability of multiple myeloma therapies.

multiple myeloma
immunotherapy

FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...

multiple myeloma

Drug Combination Design for Multiple Myeloma Using an AI Platform

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...

multiple myeloma

FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...

multiple myeloma

New Tool for Assessing Frailty May Aid in Predicting Survival in Newly Diagnosed Multiple Myeloma

A new frailty index may aid in predicting overall survival for patients newly diagnosed with multiple myeloma, according to a study published by Mian et al in JCO Clinical Cancer Informatics. This tool is important because frailty is a critical factor in treatment decision-making for ...

multiple myeloma

FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types....

multiple myeloma

Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant

The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a...

multiple myeloma

CAR T Cells Targeting B-Cell Maturation Antigen in Poor-Prognosis Relapsed Multiple Myeloma

In a first-in-human study reported in the Journal of Clinical Oncology, Brudno et al found that chimeric antigen receptor (CAR) autologous T cells targeting B-cell maturation antigen (BCMA) produced responses in patients with poor-prognosis relapsed multiple myeloma. Study Details The current...

multiple myeloma

Once- vs Twice-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma

An interim analysis of the phase III ARROW trial reported in The Lancet Oncology by Moreau et al indicated that a higher-dose once-weekly schedule of carfilzomib was associated with prolonged progression-free survival vs a twice-weekly schedule in patients with relapsed or refractory multiple...

multiple myeloma

EHA 2018: Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone vs Pomalidomide/Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma

The ELOQUENT-3 trial, an international phase II study evaluating the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically...

lung cancer
multiple myeloma

Studies of Daratumumab in Combination With Anti–PD-L1 Agents Stopped

On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs ...

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