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Showing 1351 - 1400Supplemental New Drug Application for Carfilzomib
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
Strong Showing for Anti-CD38 Antibodies in Multiple Myeloma
An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
Oral Proteasome Inhibitors Advancing in Multiple Myeloma Trials
Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
American Association for Cancer Research Inducts 2015 Class of Fellows of the AACR Academy
The American Association for Cancer Research (AACR) has announced 11 new fellows of the AACR Academy. The AACR Academy is an entity that recognizes individuals who have made exceptional contributions to cancer research and/or cancer-related biomedical science. Only individuals whose work has had a...
From ASH 2014: What’s New in the Myeloma Treatment Arsenal?
At the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, attendance at many multiple myeloma sessions outnumbered the room size, as data from studies of novel agents, such as the monoclonal antibodies, and from key trials, such as ASPIRE, drew crowds. The ASCO Post covered...
Five Questions Can Guide the Treatment of Relapsed Myeloma
Joseph Mikhael, MD, MEd, myeloma expert at the Mayo Clinic in Arizona, Scottsdale, and Associate Dean of the Mayo School of Graduate Medical Education, considers five questions when selecting treatment for patients with multiple myeloma who relapse. “With prolonged survival, which approaches 10...
Panobinostat in Combination With Bortezomib‑Dexamethasone in Previously Treated Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 23, 2015, panobinostat (Farydak) was granted...
Lenalidomide in Combination With Dexamethasone in Newly Diagnosed Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 18, 2015, the indication for lenalidomide (Revlimid)...
Winship Cancer Institute of Emory University Names New Chief Medical Officer and Chief Quality Officer
Sagar Lonial, MD, has been named Chief Medical Officer at Winship Cancer Institute of Emory University and Charles A. Staley, MD, has been named Chief Quality Officer, according to an announcement recently released by the Cancer Institute. Both physicians join Winship’s senior leadership team and...
The ASPIRE Trial of Carfilzomib in Relapsed Myeloma: A Major Step Forward
Currently in myeloma, there are at least five new agents that are either approved or in the late-stage of development with impending approval. Major questions in the field relate to how we, as clinicians, will use these new agents and where they will fit in the overall treatment schema. The phase...
Increased Progression-Free Survival With Addition of Carfilzomib to Lenalidomide/Dexamethasone in Relapsed Multiple Myeloma
In a planned interim analysis of the phase III ASPIRE trial reported in The New England Journal of Medicine, A. Keith Stewart, MB, ChB, of the Mayo Clinic, Scottsdale, Arizona, and colleagues found that the addition of the proteasome inhibitor carfilzomib (Kyprolis) to lenalidomide...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
‘Frailty Profile’ Predicts Survival and Toxicities in Elderly Patients With Multiple Myeloma
A frailty score predicts mortality and the risk of toxicity in elderly patients with multiple myeloma and can be used to determine more suitable therapies for these patients, the International Myeloma Working Group reported in Blood. “Chronologic age, performance status, and physician’s clinical...
Profile: Julie M. Vose, MD, MBA, FASCO, Making a Difference in Both Clinical Medicine and Research
At this year’s ASCO Annual Meeting, Julie M. Vose, MD, MBA, FASCO, will begin her term as the Society’s 51st President. It is fitting that the meeting will be held in Chicago, the city where the first seven visionaries met over lunch in 1964 to formulate a medical organization centered on cancer...
Remembering Multiple Myeloma Patient Advocate Michael S. Katz, MBA
I first met Michael Katz, MBA, in 2004, 3 years after my brother, Dom, was diagnosed with multiple myeloma, and we were at a crossroads in his care and needed advice. Although an experimental regimen of thalidomide (Thalomid) and dexamethasone had successfully put Dom in remission for a year (the...
MAINSAIL Trial: Worse Outcomes With Addition of Lenalidomide to Docetaxel-Prednisone in Prostate Cancer
The combination of docetaxel plus prednisone has been a standard therapy in advanced prostate cancer since 2004.1 Since then, there have been multiple randomized phase III trials comparing this standard of care with additional drug therapy. None has demonstrated improvement in outcome. Lenalidomide ...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2015 Updates
For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....
Expert Point of View: Philip L. McCarthy, MD
Another exciting multiple myeloma treatment will be presented at the 2015 ASCO Annual Meeting,” Philip L. McCarthy, MD, Professor of Oncology and Director of the Blood and Marrow Transplant Center at Roswell Park Cancer Institute, Buffalo, New York, commented in an interview with The ASCO Post....
Novel Agent Elotuzumab Added to Lenalidomide/Dexamethasone Extends Progression-Free Survival in Multiple Myeloma
The monoclonal antibody elotuzumab, given with lenalidomide (Revlimid) and dexamethasone, extended progression-free survival by a median of 5 months, compared with lenalidomide/dexamethasone alone, in the eagerly awaited phase III ELOQUENT-2 trial, which will be presented at the 2015 ASCO Annual...
ASCO Announces First-Ever Clinical Trial
ASCO announced its first-ever clinical trial, which will offer patients with advanced cancer access to molecularly targeted cancer drugs and collect “real-world” data on clinical outcomes, to help learn the best uses of these drugs outside of indications approved by the U.S. Food and Drug...
Expect Questions About Preventing Fractures After Stem Cell Transplant
Does the finding that the incidence of fractures is “compellingly higher” after hematopoietic stem cell transplantation mean that physicians counseling patients about transplant should feel compelled to discuss the fracture risks? Huifang Linda Lu, MD, PhD, the corresponding author of the study...
Incidence of Fractures Is ‘Compellingly Higher’ After Hematopoietic Stem Cell Transplantation
The incidence of fractures is “compellingly higher” after receiving hematopoietic stem cell transplantation, according to a retrospective study of patients receiving transplants for treatment of multiple myeloma, other hematologic malignancies, and some solid tumors (mostly breast and ovarian) as...
Expert Point of View: Suzanne Lentzsch, MD, PhD
Suzanne Lentzsch, MD, PhD, Director of the Multiple Myeloma and Amyloidosis Program, Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, served as the study’s discussant. She called the 29% response rate in this heavily pretreated or refractory population...
Single-Agent Daratumumab Activity Deemed ‘Remarkable’ in Refractory Multiple Myeloma
Heavily pretreated patients with multiple myeloma achieved rapid, durable, and deepening responses to the anti-CD38 monoclonal antibody daratumumab, in a phase II study presented at the 2015 ASCO Annual Meeting.1 “Daratumumab showed remarkable single-agent activity in heavily pretreated and...
Precision Medicine Trials Bring Targeted Treatments to More Patients
At the 2015 ASCO Annual Meeting, both ASCO and the National Cancer Institute (NCI) unveiled details of new precision medicine trials that will greatly expand the number of patients with cancer who are benefiting from targeted agents. The trials will match a patient’s tumor molecular profile with an ...
Carfilzomib/Dexamethasone Doubles Progression-Free Survival vs Bortezomib/Dexamethasone in Patients With Relapsed Multiple Myeloma
In the first head-to-head study comparing two proteasome inhibitors in relapsed multiple myeloma, carfilzomib (Kyprolis)/dexamethasone provided a doubling in progression-free survival, compared with bortezomib (Velcade)/dexamethasone.1 Results of the phase III ENDEAVOR trial of the two regimens in...
Collaborating Toward a Cure
We’ve seen how dramatically patients’ lives can change when they are matched with the right treatment at the right time in their disease course. Although this is still an exception and not the rule, we believe collaborative research approaches will make this kind of precision medicine a reality for ...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...
2015–2016 ASCO President Julie M. Vose, MD, MBA, FASCO: Leading During a Year of Historic Changes
Julie M. Vose, MD, MBA, FASCO, began her term as the 2015–2016 President of ASCO at the 2015 Annual Meeting on June 1, 2015. Dr. Vose, a leading expert in the treatment of patients with lymphoma, is the current Neumann M. and Mildred E. Harris Professorial Chair and Chief of the Oncology/Hematology ...
Study Shows Current Blood Cancer Drug Prices Are Not Justified
The costs associated with cancer drug prices have risen dramatically over the past 15 years, a trend concerning to many oncologists. In a new analysis, researchers at The University of Texas MD Anderson Cancer Center concluded the majority of existing treatments for hematologic cancers are...
Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 24, 2015, carfilzomib (Kyprolis) was approved for use in...
FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. In the United States, there are nearly...
Elotuzumab Ushers in a New Era in Myeloma Therapy
The long wait for monoclonal antibodies for the treatment of multiple myeloma is over. In the landmark ELOQUENT-2 study, reviewed in this issue of The ASCO Post, Lonial and colleagues convincingly demonstrate the effectiveness of elotuzumab, a monoclonal antibody directed against SLAMF7, in the...
Adding Elotuzumab to Lenalidomide Plus Dexamethasone Improves Progression-Free Survival in Refractory Multiple Myeloma
In an interim analysis of the phase III ELOQUENT-2 trial reported in The New England Journal of Medicine, Sagar Lonial, MD, of Emory University School of Medicine, Meletios Dimopoulos, MD, of National and Kapodistrian University of Athens, and colleagues found that the addition of elotuzumab to...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
Bristol-Myers Squibb and AbbVie recently announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
NCI Awards SPORE Grant to Mayo Clinic Multiple Myeloma Research Team
A team of Mayo Clinic Cancer Center scientists has been awarded a Specialized Program of Research Excellence (SPORE) grant in multiple myeloma from the National Cancer Institute. The Center is one of only three cancer centers to receive a SPORE grant for multiple myeloma cancer research. “With...
Making Their Voices Heard: 118 Oncologists Speak Out About Stemming the High Cost of Cancer Drugs
In a bold move to shed light on the ramifications of the ever-increasing cost of cancer drugs for patients with cancer and for the health-care system, 118 prominent oncologists came together to write a commentary in Mayo Clinic Proceedings detailing their concerns.1 To learn more about these...
Bart Barolgie, MD, Joins Tisch Cancer Institute at Mount Sinai
Bart Barlogie, MD, a myeloma expert who introduced the first curative therapy for multiple myeloma, a multidrug regimen known as Total Therapy 3, is joining the faculty of Tisch Cancer Institute of the Icahn School of Medicine at Mount Sinai (ISMM. Dr. Barlogie will serve as Director of Research in ...
MMRF Announces Enrollment Completion of CoMMpass Study
The Multiple Myeloma Research Foundation (MMRF) announced that the MMRF CoMMpass StudySM, the most comprehensive long-term genomic study ever conducted in myeloma, has reached full enrollment, with 1,000 patients now participating. The global study is mapping the genomic profile of each enrolled...
Patient and Survivor Care Studies Yield Useful Results to Improve Quality of Life
Recent studies have yielded useful results that clinicians can put into practice, some right now, to help improve the quality of life for patients with cancer. Concerns addressed included cachexia, pain, “chemobrain,” and fertility preservation. At the Best of ASCO®/Chicago meeting, Arif Kamal,...
NCCN Turns 20: Value-Based Care Has Arrived
Twenty years ago, the National Comprehensive Cancer Network (NCCN) began as a cooperative effort of 12 prestigious cancer centers, working to define and promote national guidelines for the care of patients with cancer. A major goal was to encourage uniformity in the management of malignant...
Equanimity
The following essay by S. Vincent Rajkumar, MD, is adapted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and thebigcasino.org. It was...
NCCN Unveils Graphic Evidence Blocks to Guide Decision-Making
Treatment decision-making for oncologists and their patients may become simpler through the use of graphic NCCN Evidence Blocks™, which were unveiled at the NCCN 10th Annual Congress: Hematologic Malignancies™ sponsored by the National Comprehensive Cancer Network® (NCCN¨). The first of the NCCN...
CAR T-Cell Immunotherapy Saved My Life
I have always prided myself on being healthy and fit, so when I started experiencing a chronic cough, difficulty breathing, and pain in my ribs and back, I thought they were the inevitable symptoms of a severe cold. At 42 and the mother of three children, it was inconceivable to me that I could...
Daratumumab Approved in Multiple Myeloma
The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome...
Clinical Trials Actively Recruiting Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma, and Myeloma
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with Hodgkin lymphoma, non-Hodgkin lymphoma, and myeloma. The trials are investigating combination treatments; modified chemotherapy regimens; autologous hematopoietic cell...
ASCO Launches TAPUR to Assess the Off-Label Use of Targeted Therapies for Patients With Advanced Cancers
Two years ago, Richard L. Schilsky, MD, FACP, FASCO, Chief Medical Officer of ASCO, proposed a unique clinical trial concept during an educational session on the challenges of delivering precision medicine services in a community setting at ASCO’s Annual Meeting. The idea was to design a clinical...
TAPUR: ASCO’s First Clinical Trial Addresses Critical Gaps in Understanding of and Access to Targeted Therapies
ASCO is preparing to expand the boundaries of precision medicine with the launch of its first clinical trial. At a press briefing during the 2015 ASCO Annual Meeting, the Society formally announced its plans for the Targeted Agent and Profiling Utilization Registry (TAPUR) study. At a time when...
