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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

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).

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

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...

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 ...

multiple myeloma
immunotherapy

2018 ASCO: Pomalidomide, Bortezomib, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

For patients with multiple myeloma who have been treated with lenalidome (Revlimid) but have relapsed and not responded to other therapy, a three-drug combination can significantly extend the time in which the disease is held in check. The findings of the phase III OPTIMISMM trial were presented by ...

multiple myeloma

Aviva C. Krauss, MD, on Multiple Myeloma: Treatment Trials Analysis

Aviva C. Krauss, MD, of the U.S. Food and Drug Administration, discusses findings on an FDA analysis of immune-related adverse events and response to pembrolizumab in multiple myeloma (Abstract 8008).

multiple myeloma
immunotherapy

FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible

On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...

multiple myeloma
symptom management

Analysis of Carfilzomib-Related Cardiotoxicity

In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...

multiple myeloma
immunotherapy

Pomalidomide and Low-Dose Dexamethasone in Patients With Multiple Myeloma and Renal Impairment

In a European phase II trial reported in the Journal of Clinical Oncology, Dimopoulos et al found that pomalidomide (Pomalyst) plus low-dose dexamethasone produced responses in patients with relapsed or refractory multiple myeloma and renal impairment. Study Details In the study, 81 patients with ...

multiple myeloma
immunotherapy

ASPIRE Trial: Final Overall Survival Results in Relapsed or Refractory Multiple Myeloma

The final overall survival results of the phase III ASPIRE trial indicate significant improvement with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) vs lenalidomide plus dexamethasone (Rd) in patients who had received one to three prior lines of therapy for multiple...

multiple myeloma
immunotherapy

FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting

On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...

multiple myeloma

ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma

The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...

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...

multiple myeloma

Maria-Victoria Mateos, MD, PhD, on Multiple Myeloma: Results From the ALCYONE Trial

Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, discusses phase III study findings on daratumumab plus bortezomib, melphalan, and prednisone vs bortezomib, melphalan, and prednisone in patients ineligible for transplant who have been newly diagnosed with multiple myeloma...

multiple myeloma

ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma

A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...

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...

multiple myeloma

Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma

In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...

multiple myeloma

Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed/Refractory Multiple Myeloma

On October 23, topline results of the phase III ARROW trial were announced, showing carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than...

multiple myeloma

NCCN Guidelines to Include Categories of Preference

The National Comprehensive Cancer Network® (NCCN®) has instituted Categories of Preference for recommendations within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Initially, Categories of Preference will be published for drugs and biologics recommended within...

multiple myeloma

Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma

As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...

multiple myeloma

FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma

On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...

multiple myeloma

Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma

On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...

multiple myeloma

Lenalidomide Maintenance After Autologous Stem Cell Transplantation in Multiple Myeloma

According to a meta-analysis reported in the Journal of Clinical Oncology by McCarthy et al, lenalidomide (Revlimid) maintenance therapy after autologous stem cell transplantation (ASCT) was associated with improved progression-free and overall survival vs placebo or observation in patients with...

multiple myeloma

Comparison of MRI vs PET-CT in Multiple Myeloma

A study reported by Moreau et al in the Journal of Clinical Oncology indicated no difference between magnetic resonance imaging (MRI) and positron-emission tomography–computed tomography (PET-CT) in detecting bone lesions at diagnosis in patients with multiple myeloma. PET-CT normalization...

multiple myeloma

FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma

On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...

multiple myeloma

EHA 2017: Ixazomib Plus Lenalidomide/Dexamethasone in Newly Diagnosed Multiple Myeloma With No Stem Cell Transplant, Followed by Maintenance Ixazomib

Data from two phase I/II clinical trials evaluating ixazomib (Ninlaro) in patients with newly diagnosed multiple myeloma was presented at the 2017 European Hematology Association (EHA) Annual Meeting (Abstracts S408, S780). Both studies evaluated ixazomib plus lenalidomide (Revlimid) and...

multiple myeloma
cost of care

Impact of Subsidies on Use of Oral Immunomodulatory Drugs in Medicare Beneficiaries With Myeloma

According to a study by Olszewski and colleagues in the Journal of Clinical Oncology, Medicare Part D beneficiaries without a low-income subsidy may face daunting barriers in affording oral immunomodulatory drugs for myeloma. The low-income subsidy markedly reduces out-of-pocket costs for...

multiple myeloma

FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved the use of daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a...

solid tumors
lymphoma
multiple myeloma

ASCO's TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators

ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drug, more than 100 sites, new partnerships, and a revised protocol to lower the age of eligibility. “We are very pleased with the...

multiple myeloma

ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed/Refractory Multiple Myeloma Into Lasting Remission in an Early Trial

In an early clinical trial, 33 out of 35 (94%) patients had clinical remission of multiple myeloma upon receiving immunotherapy with chimeric antigen receptor (CAR) T cells targeting B-cell maturation protein, or BCMA. Most patients had only mild side effects. The study was presented by Fan et al...

multiple myeloma

Spanish Analysis of Prognostic Impact of MRD-Negative Status in Multiple Myeloma

A pooled analysis of three PETHEMA/GEM studies has shown that minimum residual disease (MRD)-negative status after induction therapy is more prognostic of favorable outcome than complete response alone in newly diagnosed multiple myeloma. The findings were reported by Lahuerta et al in the Journal...

multiple myeloma

Lenalidomide, Bortezomib, and Dexamethasone With or Without HCT in Younger Patients With Multiple Myeloma

A French phase III trial (IFM 2009), reported by Attal et al in The New England Journal of Medicine, has shown that consolidation treatment with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVD) was associated with poorer progression-free survival vs high-dose chemotherapy and...

multiple myeloma

FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant

On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant. The expanded indication makes...

multiple myeloma

Does Obesity Pose Risk for Transformation of Monoclonal Gammopathy of Undetermined Significance to Myeloma?

In a population-based cohort study reported in the Journal of the National Cancer Institute, Chang et al found that overweight and obesity were associated with an increased risk of transformation of monoclonal gammopathy of undetermined significance to multiple myeloma. Black race was also...

multiple myeloma

Does Adding Bortezomib to Lenalidomide/Dexamethasone Improve Outcomes in Patients With Newly Diagnosed Myeloma?

In the phase III SWOG S0777 trial reported in The Lancet, Durie et al found that adding bortezomib (Velcade) to lenalidomide (Revlimid)/dexamethasone improved progression-free and overall survival in patients with newly diagnosed myeloma who were not planned for immediate autologous stem cell...

multiple myeloma

ASH 2016: Additions to Standard Multiple Myeloma Therapy Do Not Appear to Yield Additional Benefit

Trial results presented by Stadtmauer during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-1) suggest two therapies that are often added to standard therapy in patients with multiple myeloma do not improve rates of progression-free survival ...

multiple myeloma

FDA Approves Daratumumab in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Multiple Myeloma

On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior...

multiple myeloma

Weight Loss May Help Prevent Multiple Myeloma

New research shows that excess weight increases the risk that a benign blood disorder will progress to multiple myeloma. The study, by a team at Washington University School of Medicine in St. Louis, is published in the Journal of the National Cancer Institute. Being overweight or obese has been...

multiple myeloma

Lower Risk of All-Cause Mortality in Multiple Myeloma Reported With Treatment at Higher-Volume Facilities

In an analysis of data from the National Cancer Database reported in the Journal of Clinical Oncology, Go et al found a lower risk of all-cause mortality among patients with multiple myeloma treated at higher-volume facilities. Study Details The study included patients diagnosed with multiple...

multiple myeloma

Does Adding Daratumumab to Lenalidomide/Dexamethasone Improve Outcomes in Previously Treated Multiple Myeloma?

The addition of the CD38-targeted antibody daratumumab (Darzalex) to lenalidomide (Revlimid)/dexamethasone improved progression-free survival in patients with previously treated multiple myeloma, according to the results of the phase III POLLUX trial reported by Dimopoulos et al in The New England...

multiple myeloma

Katja Weisel, MD, on Multiple Myeloma: Results of the CASTOR Study (German Language Version)

Katja Weisel, MD, of the University of Tübingen, discusses in German study findings on daratumumab, bortezomib, and dexamethasone vs bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. (Abstract 906O)

multiple myeloma

Katja Weisel, MD, on Multiple Myeloma: Results of the CASTOR Study

Katja Weisel, MD, of the University of Tübingen, discusses study findings on daratumumab, bortezomib, and dexamethasone vs bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. (Abstract 906O)

multiple myeloma

Meta-analysis Shows Association of Minimal Residual Disease–Negative Status With Improved Survival in Multiple Myeloma

In a meta-analysis reported in JAMA Oncology, Munshi et al found that minimal residual disease (MRD)-negative status was associated with improved survival in patients with newly diagnosed multiple myeloma. For the analysis, a literature search identified 21 English language articles published...

hematologic malignancies
multiple myeloma

Study Finds Statin Use Associated With Reduced Mortality in Multiple Myeloma

Analysis of data from the Veterans Administration Central Cancer Registry, reported in the Journal of Clinical Oncology by Sanfilippo et al, showed that statin use was associated with a reduced risk of all-cause and multiple myeloma–specific mortality in patients with multiple myeloma....

multiple myeloma

Improved Quality of Life Reported With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed Multiple Myeloma

As reported in the Journal of Clinical Oncology, Stewart et al found that treatment with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) was associated with improved health-related quality of life vs lenalidomide/dexamethasone (Rd) in relapsed multiple myeloma in the phase...

multiple myeloma

Adding Daratumumab to Bortezomib/Dexamethasone Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma

In the phase III CASTOR trial reported in The New England Journal of Medicine, Palumbo et al found that adding the anti-CD38 antibody daratumumab (Darzalex) to bortezomib (Velcade) and dexamethasone markedly improved progression-free survival among patients with relapsed or relapsed and refractory...

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