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Showing 10751 - 10800FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
Colon Cancer Surgery and Resource Availability at Hospitals on Weekends and Holidays
The likelihood of severe complications after emergency colon cancer surgery is significantly higher over the weekend, according to a study published by Huijts et al in JNCCN – Journal of the National Comprehensive Cancer Network. The research was led by Perla Marang-van de Mheen, PhD, of the...
FDA Takes Steps to Foster Greater Efficiency in Biosimilar Development by Reconsidering Draft Guidance on Evaluating Analytical Studies
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the US Food and Drug Administration (FDA) can do more to support the development of biosimilars, as well as...
IASLC Issues Statement Paper on Liquid Biopsy for Lung Cancer
The lungs can be a difficult organ to biopsy with a needle, so the promise of identifying lung cancer through a blood-based biopsy has lung cancer experts and patients optimistic. Knowing how and when to use a liquid biopsy is critically important and led global experts at the International...
Second-Line Pembrolizumab vs Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...
Dietary Insulin Load and Risk of Disease Recurrence in Stage III Colon Cancer
New research led by Dana-Farber Cancer Institute investigators suggests that patients treated for nonmetastatic colon cancer may sharply reduce the risk that the disease will return by following a diet low in carbohydrates and other foods that raise insulin levels. In a study published by...
FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...
JAK Inhibitor Treatment for Myelofibrosis May Be Associated With Development of Aggressive Lymphomas
Austrian researchers have discovered that a small number of patients taking targeted drugs known as Janus kinase (JAK) inhibitors to treat myelofibrosis may develop aggressive lymphomas. They also speculate that screening for a preexisting B-cell clone before starting therapy may help prevent this...
Outcomes by Chemotherapy Backbone for Obinutuzumab vs Rituximab in Previously Untreated Follicular Lymphoma
In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...
In Continued Effort to Address Physician Burnout, AMA Adopts Policy to Improve Physician Access to Mental Health Care
With growing concern among the medical community and the public regarding physician and medical student depression, burnout, and suicide, the American Medical Association (AMA) adopted policy during its Annual Meeting that continues its efforts aimed at improving physician access to mental health...
FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...
Bipolar Androgen Therapy After Disease Progression in Metastatic Castration-Resistant Prostate Cancer
In a single-center phase II study reported in The Lancet Oncology, Teply et al found that bipolar androgen therapy can induce prostate-specific antigen (PSA) response and resensitization to enzalutamide (Xtandi) in men with metastatic castration-resistant prostate cancer whose disease progressed on ...
Addition of Tumor-Treating Fields to Maintenance Temozolomide in Glioblastoma
The final results of a phase III trial reported by Roger Stupp, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved...
Endangered Art of Medicine
I hold a cold, lifeless mouse instead of my patient’s heated hand, checking off the tiny box marked “Anxiety,” while she squirms under twisted blankets. I don’t remember when or how or why it happened, that the static screen wedged itself between my patients and me and compliance with the digital...
I’m Proud to Have Contributed to the FDA Approval of CAR T-Cell Therapy
When I was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2013, I used to joke that if I had to get cancer, this wasn’t a bad one to have. At just 32, I was otherwise healthy, and my prognosis for a cure was good, according to my oncologist. So I felt confident that once I underwent...
Colorectal Cancer Alliance Announces Available Research Funding
THE COLORECTAL CANCER Alliance has announced up to $775,000 in available funding for up to five grants supporting research in young-onset colorectal cancer, rectal cancer, and colorectal cancer prevention. The Colorectal Cancer Alliance is committed to investing $10 million in research by 2021,...
Researchers at Baylor Awarded Multiple Grants to Study Treatment Resistance in Breast Cancer
TO BETTER UNDERSTAND the causes of resistance to treatment in estrogen receptor–positive breast cancer, the Department of Defense has awarded researchers at Baylor College of Medicine multiple grants to study gene anomalies in estrogen receptor–positive breast cancer that are associated with...
Disparities Found in Lung Cancer Care, Survival in United States vs England
DESPITE STEADY declines in death rates in recent years, lung cancer remains the leading cause of cancer deaths in wealthy countries. In a study published by Anita Andreano, MD, of the University of Milan-Ciocco, and colleagues in the Journal of Thoracic Oncology,1 Yale researchers collaborated with ...
Actively Recruiting Clinical Trials Focused on Pancreatic Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pancreatic cancer. These studies are investigating radiotherapy; cancer vaccines; combination treatments; novel cell therapies; response prediction; and more. All of the studies ...
Handheld Device for Detecting Heart Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer
Cardiovascular complications, such as anthracycline-related heart failure, are a leading cause of morbidity and mortality in survivors of childhood cancer, often developing at a time when these survivors are least engaged in long-term survivorship care, prompting the need for new paradigms in...
FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9). The application is seeking approval for an expanded age...
Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for ...
AMA Plans Advocacy Outreach to Expand Colorectal Screening
Building on the efficacy of colorectal cancer screening, the American Medical Association (AMA) endorsed a plan at its Annual Meeting to work with physicians and payers to make the screening more available and affordable. Challenges with insurance coverage remain a barrier to colorectal cancer...
Suboptimal Use of Initial Chemotherapy in Newly Diagnosed AML
In a study of National Cancer Database data reported in Blood Advances, Bhatt et al found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that chemotherapy is associated with a survival benefit and improvement in symptoms ...
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 ...
From Italy to Boston, A Love of Molecular Diagnostics Shapes a Career for Valentina Nardi, MD
Valentina Nardi, MD, is a staff pathologist at Massachusetts General Hospital, and her current clinical work includes implementing molecular assays for hematologic malignancies at the Center for Integrated Diagnostics. “I was born in Rome, but I did my high school and college education in Genoa. I ...
How Learning What’s on Your Patient’s Bucket List May Improve Care
It may sound too good to be true, but asking patients a simple question about what is on their bucket list can actually spark a dialogue about how best to make their cancer care and survivorship fit into their life plans, as well as be an effective way to identify their end-of-life care goals,...
Voluntarily Stopping Eating and Drinking Is Legal—and Ethical—for Terminally Ill Patients Looking to Hasten Death
Terminally ill patients with cancer will sometimes ask their clinicians for help with assisted or hastened death.1 Although palliative care and hospice care can usually address the concerns of most patients, some have physical or existential suffering that is refractory to comfort and supportive...
Patients With AML Have Reduced Risk of Early Mortality at NCI-Designated Cancer Centers
RESEARCHERS AT the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...
Register Today for the ASCO Research Community Forum 2018 Annual Meeting
This year’s ASCO Research Community Forum (RCF) 2018 Annual Meeting will not be one to miss! Though still a few months away, I am thrilled to share the work that is already underway to bring the research community together for 2 days of learning and collaboration. During my term as Chair of the...
Resilience While Caring for Seriously Ill Patients: Skills and Strategies to Prevent Burnout
A career in oncology can be extremely rewarding. Fast-paced advances in research and treatment, exciting changes in the practice environment, and the opportunity to build strong relationships with and provide critical support to patients can be incredibly professionally satisfying—but they can...
Regular Mammograms Linked to Less Aggressive Treatment in Patients With Breast Cancer
A STUDY evaluating the impact of breast cancer screening has shown that the benefits of regular mammograms extend well beyond reduced mortality. According to data presented at the American Society of Breast Surgeons (ASBrS) 2018 Annual Meeting, women with breast cancer who underwent regular...
AJCC Breast Cancer Staging System More Clinically Relevant
THE RECENTLY issued 8th revision to the American Joint Committee on Cancer (AJCC) Breast Cancer Staging System incorporates tumor biology and prognostic stage groups and thus has become more accurate and clinically relevant, according to two speakers at the 2018 Miami Breast Cancer Conference.1,2...
Be Counted—Complete the 2018 ASCO Practice Census Today
ASCO invites you to participate in the 2018 ASCO Practice Census. Just as you monitor the health of your patients, ASCO regularly gathers information on the oncology practice environment, and we need your help to do so. The ASCO Practice Census is an annual survey designed to capture comprehensive, ...
Changes to Maintenance of Certification: New Pathways for Assessment
As you know, for more than 2 years, ASCO has been working closely with the American Board of Internal Medicine (ABIM) to shape the future of maintenance of certification (MOC) and assessment for our specialty. The ASCO MOC Task Force was charged by ASCO’s membership to make the process for...
Prostate Cancer Therapy in Evolution: Time to Rethink and Redirect?
The ASCO updated guidelines on the treatment of metastatic non-castrate prostate cancer penned by Morris and his colleagues1 provide valuable information annotated to the strengths of evidence in recently reported prostate cancer studies. CHAARTED, GETUG-AFU 15, LATITUDE, and STAMPEDE have...
De Novo Metastatic Prostate Cancer: Positive Recent News, Many Open Questions
After about 70 years with no significant progress, the landscape for men with de novo metastatic prostate cancer has changed dramatically in the past 4 years, with statistically significant and highly clinically meaningful survival improvement reported from multiple phase III trials when...
DNA Test Identifies Men With Sixfold Increased Risk of Prostate Cancer
A major new study of more than 140,000 men has identified 63 new genetic variations in the DNA code that increase the risk of prostate cancer. These findings were published by Schumacher et al in Nature Genetics. Researchers devised a new test combining these single-letter genetic variants with...
Parents See Cancer Prevention Potential as Best Reason for HPV Vaccination
Parents of adolescents believed that the potential to prevent certain types of cancer is the best reason for their children to receive the human papillomavirus (HPV) vaccine, whereas other reasons health-care providers often give were far less persuasive. Findings from this study were published by...
ASCO/CAP Clinical Practice Guideline Focused Update on HER2 Testing in Breast Cancer
As reported in the Journal of Clinical Oncology by Antonio C. Wolff, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and colleagues, ASCO and the College of American Pathologists (CAP) have issued a clinical practice guideline focused update on HER2 testing in breast cancer....
ASCO Clinical Practice Guideline: Optimizing Anticancer Therapy in Metastatic Non-castrate Prostate Cancer
As reported in the Journal of Clinical Oncology by Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, and colleagues, ASCO has released a clinical practice guideline on optimizing anticancer therapy in men with metastatic non-castrate prostate cancer.1 To ...
Expert Point of View: Naiyer Rizvi, MD
“In CheckMate 227, the benefit of nivolumab [Opdivo] plus ipilimumab [Yervoy] was the same in tumor mutational burden–high patients whether or not they were programmed cell death ligand 1 (PD-L1)–high or –low,” said formal discussant of this paper, Naiyer Rizvi, MD, Director of Thoracic Oncology...
Nivolumab Plus Ipilimumab Improves Progression-Free Survival in NSCLC With High Tumor Mutational Burden
The combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved progression-free survival compared with chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) and a high tumor mutational burden irrespective of programmed cell death ligand 1...
11 New Institutions Join AACR Project GENIE Consortium
The number of institutions participating in the American Association for Cancer Research (AACR) initiative, AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE), has increased by 11 participants. The 11 new institutions of the AACR Project GENIE consortium and their related cancer...
Optimizing Biologics in Metastatic Colon Cancer
Biologics are credited with increasing median overall survival in colorectal cancer to approximately 30 months. Their optimal use was discussed by Axel Grothey, MD, Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, in an article he coauthored for the Journal of Oncology Practice 1...
Expert Point of View: Amir Fathi, MD, and Eunice S. Wang, MD
Commenting on this study, Amir Fathi, MD, a hematologist/oncologist at Massachusetts General Hospital and a co-investigator on the study, expressed hope about this new targeted approach. “Ivosidenib is an oral targeted inhibitor of the altered isocitrate dehydrogenase-1 (IDH1) protein. This...
Phase I Study Shows Safety, Efficacy of Ivosidenib in Acute Myeloid Leukemia
Ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, yielded durable and molecular remissions in some patients with IDH1-mutated advanced relapsed or refractory acute myeloid leukemia (AML). At a dose of 500 mg/d, ivosidenib was associated with a low frequency of grade 3 or higher...
Esomeprazole With Aspirin in Patients With Barrett’s Esophagus
An updated analysis of a randomized phase III trial showed that taking a high dose of esomeprazole with low-dose aspirin for at least 7 years may moderately reduce the risk of developing high-grade dysplasia or esophageal cancer and may delay death from any cause in people with Barrett’s esophagus. ...
