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Showing 851 - 900FDA 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...
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...
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.
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.
FDA Grants Rare Pediatric Disease Designation to CLR 131 in Treatment of Osteosarcoma
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to CLR 131 for the treatment of osteosarcoma. CLR 131 has received Rare Pediatric Disease designation in four pediatric cancers: neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and now...
CAR T-Cell Therapy for CLL
A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....
Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
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 June 13, 2018, pembrolizumab (Keytruda) was granted...
NCCN and CAOH Develop Guidelines to Improve Cancer Care in the Caribbean
The National Comprehensive Cancer Network® (NCCN®) is embarking on a new collaboration with the Caribbean Association for Oncology & Hematology (CAOH) to develop a library of NCCN Harmonized Guidelines™ for the Caribbean. The archipelago that extends from the Bahamas in the north to Trinidad...
Improving the Lives of Patients With Cancer Is Richard L. Schilsky’s Lifelong Mission
In 2009, as Richard L. Schilsky, MD, FACP, FSCT, FASCO, was preparing his Presidential Address for that year’s ASCO Annual Meeting, he came across his 6th grade essay titled “My Ambition,” which foretold with eerie specificity the career path he would follow over the next 6 decades. In the paper,...
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...
New Tool for Assessing Frailty Predicts Survival in Newly Diagnosed Multiple Myeloma
A new frailty index predicts overall survival for patients newly diagnosed with multiple myeloma, according to a study recently published in JCO Clinical Cancer Informatics (JCO CCI). This tool is important because frailty is a critical factor in treatment decision-making for many patients with...
Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma
In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on...
Venetoclax and Beyond: Successfully Targeting BCL2
Although many agents have been able to successfully inhibit the proliferative capacity of cancer cells or disable mutations that spur cancer growth, one area that has proven elusive is the apoptotic pathway—the cell’s means of resisting death. That is until recently. Dysregulation of B-cell...
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...
New Tool for Assessing Frailty in Patients With Newly Diagnosed Multiple Myeloma
A NEW “frailty index” may predict overall survival for patients newly diagnosed with multiple myeloma, according to a study published in JCO Clinical Cancer Informatics.1 Frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as many of these patients are ...
New Frontiers Being Explored in Multiple Myeloma
BEFORE TOO LONG, oncologists can expect to have an entirely new arsenal in the fight against multiple myeloma. Cutting-edge therapies on the near horizon were described in a presentation by Kenneth Anderson, MD, at the 2018 American Association of Cancer Research’s (AACR’s) inaugural conference on...
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...
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 ...
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....
Sagar Lonial, MD, on Multiple Myeloma: Sequencing Therapies
Sagar Lonial, MD, of the Emory University School of Medicine, discusses the importance of planning for relapse based on the treatment a patient has received, new targets for refractory myeloma, and the role of cellular therapy.
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...
Expert Point of View: Parameswaran Hari, MD
FORMAL DISCUSSANT Parameswaran Hari, MD, of the Medical College of Wisconsin, Milwaukee, was impressed by many aspects of the bb2121 study, which represents the “largest and most mature” data set for the chimeric antigen receptor (CAR) T-cell approach in myeloma, he noted. According to Dr. Hari,...
CAR T-Cell Therapy: Updated Data Remain Favorable in Heavily Pretreated Patients With Myeloma
IN AN UPDATE of a phase I trial, a heavily pretreated population of patients with multiple myeloma continued to respond to the chimeric antigen receptor (CAR) T-cell therapy bb2121.1 The results presented at the 2018 ASCO Annual Meeting confirmed previous findings for bb2121 in the dose-escalation...
Expensive Cancer Drugs Don’t Work if Patients Can’t Afford Them
Eight years ago, I was having a series of colds I couldn’t shake and pain that radiated throughout my back. Still, my symptoms weren’t concerning until, on Halloween morning in 2010, I stepped out of bed and fell to the floor in excruciating pain, unable to move. A visit to the emergency room and a ...
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...
Jens Hillengass, MD, Named Chief of Myeloma at Roswell Park
JENS HILLENGASS, MD, has been announced as the new Chief of Myeloma of the Roswell Park Comprehensive Cancer Center. As part of his new role, Dr. Hillengass will continue his research on hematologic diseases, including multiple myeloma and its precursor diseases. A scientist with more than 15...
Green Tea
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on the potential health benefits ...
Harvard Business School Launches Initiative to Accelerate Precision Medicine in Oncology
THE HARVARD BUSINESS School Kraft Precision Medicine Accelerator, a multidisciplinary initiative with aims to advance precision medicine, focuses on four workstreams: Direct to Patient, Data & Analytics, Clinical Trials, as well as Venture and Investment. It was recently announced that under...
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...
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...
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 ...
ASCO’s TAPUR Study Website Now Features Updates on Patient Cohort Expansions and Closures
ASCO’S TARGETED Agent and Profiling Utilization Registry (TAPUR) Study now provides a full list of patient cohort expansions and closures on its website. Based on treatment responses in stage I, patient cohorts are either expanded to stage II for further study and identification of a signal or...
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 ...
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).
FDA Grants Orphan Drug Designation to Galinpepimut-S for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to galinpepimut-S for the treatment of multiple myeloma. The drug is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor...
Stand Up To Cancer Launches Research Team to Detect Precursor Conditions of Multiple Myeloma
Stand Up To Cancer (SU2C) announced a $10 million award to a Stand Up To Cancer Dream Team focused on revolutionizing the treatment of multiple myeloma through the early detection of precursor conditions. In the hope of developing therapies to prevent myeloma in high-risk populations, the project...
The American Society of Clinical Oncology at a Glance
The American Society of Clinical Oncology (ASCO) held its first scientific Annual Meeting on April 9, 1965, in the Bellevue Stratford Hotel in Philadelphia. More than 70 members and invited guests attended the inaugural event, which featured three presentations on leukemia and multiple myeloma. The ...
Weighing the Cost and Value of CAR T-Cell Therapy
This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...
FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma
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 ineligible for...
