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Showing 10451 - 10500FDA Announces Comprehensive Regenerative Medicine Policy Framework
On November 16, the U.S. Food and Drug Administration (FDA) announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework—outlined in a suite of four guidance documents—builds upon the...
Differences in Insurance Coverage Associated With Nearly Half of Black-White Survival Disparity in Colorectal Cancer
Health insurance coverage differences account for nearly one-half of the black-white survival disparity in colorectal cancer patients, according to a new study published by Sineshaw et al in Gastroenterology. The findings reinforce the importance of equitable health insurance coverage to mitigate...
ESMO Publishes Precision Medicine Glossary
The European Society for Medical Oncology (ESMO) has published its ESMO Precision Medicine Glossary in Annals of Oncology. The glossary’s 43 definitions are set to pave the way for consistent communication on precision medicine between oncologists, researchers, and patients by standardizing...
Hospital Groups File Lawsuit to Stop Significant Payment Cuts for 340B Hospitals
The American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), and America’s Essential Hospitals have filed a lawsuit against the U.S. Department of Health and Human Services (HHS) in the U.S. District Court for the District of Columbia to prevent significant...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
FDA Authorizes MSK-IMPACT Tumor Profiling Assay
Today, the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s MSK-IMPACT tumor profiling assay, an in vitro diagnostic test that can identify more biomarkers that may be found in various cancers than any test previously reviewed by the...
Ventana MMR IHC Panel for Patients Diagnosed With Colorectal Cancer Receives FDA Clearance
On November 14, the U.S. Food & Drug Administration (FDA) granted clearance to the Ventana MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect proteins associated with the DNA...
TMPRSS2-ERG Genetic Fusion May Be Associated With Low-Risk Prostate Cancer
Establishing the way in which a genetic alteration called a TMPRSS2-ERG gene fusion forms in a prostate cancer, rather than the presence of the gene fusion itself, could help identify patients with prostate cancer with a low risk of spreading, which might determine the best course of treatment for...
Chronic Stress Hormones May Promote Resistance to EGFR Inhibitors in Patients With Lung Cancer
Elevated levels of chronic stress hormones, such as those produced by psychological distress, may promote resistance to drugs commonly used to treat lung cancer patients with EGFR mutations, according to new research from The University of Texas MD Anderson Cancer Center. Retrospective analysis of...
Donald Coffey, PhD, Prostate Cancer Expert, Dies at 85
Donald Coffey, PhD, a distinguished Johns Hopkins professor and prostate cancer expert, who was the former Director of the Brady Urological Research Laboratory and Deputy Director of the Johns Hopkins Kimmel Cancer Center, died on November 9 at the age of 85. Long Career at Johns Hopkins In his...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy. ALCANZA...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
ARIEL3 Investigators Clarify the Effects of Rucaparib on the Liver
PRIMARY RESULTS from the randomized, placebo-controlled, phase III study ARIEL3—presented at the European Society for Medical Oncology (ESMO) 2017 Congress and published recently in The Lancet1—demonstrated that maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib ...
Life With Death in the Room
It began, as so many do, with what a doctor often calls “a small spot,” a vague description that makes a potentially fatal disease sound like something that, with a slight bit of attention, can be ridded, like erasing a misplaced comma. In 2015, during a routine mammogram, doctors found one “small ...
A Revolutionary Technology Offers Hope and Ethical Concern
Aldous Huxley’s classic 1932 dystopian novel Brave New World pictures an eerie future where humans are genetically bred, altered to create worthy citizens. Welcome back to the future. First there was the astounding feat of sequencing the entire human genome; now, thanks to a revolutionary...
Higher Risk of Breast Cancer Does Not Motivate Cancer Screening in Many Women
Some women, because of genetic predisposition, personal, or family history, have a higher-than-average lifetime risk of developing breast cancer. For those women, earlier magnetic resonance imaging (MRI) is recommended for cancer screening. But according to new findings presented at the American...
Gerold Bepler, MD, PhD, Elected to Association of American Cancer Institute’s Board of Directors
GEROLD BEPLER, MD, PhD, President and Chief Executive Officer of the Barbara Ann Karmanos Cancer Institute, has been elected to serve a 3-year term on the Association of American Cancer Institutes (AACI) Board of Directors. AACI comprises 97 leading cancer research centers in North America and is...
New Cancer Care Collaboration Brings Memorial Sloan Kettering Cancer Care to Norwalk Hospital
NORWALK HOSPITAL and Memorial Sloan Kettering Cancer Center (MSK) announced a new cancer care collaboration that will integrate MSK medical and radiation oncologists and care practices with the existing cancer program at the C. Anthony and Jean Whittingham Cancer Center at Norwalk Hospital. For...
National Cancer Institute Awards Dr. Ruth Etzioni 5-Year Grant to Fill Gaps in Cancer-Recurrence Data
RUTH ETZIONI, PhD, a Biostatistician at Fred Hutchinson Cancer Research Center’s Public Health Sciences Division, has received a 5–year National Institutes of Health grant to advance the science of cancer surveillance by developing, validating, and deploying a scalable and automated approach for...
Two Individuals Recognized With NCCS Ellen L. Stovall Award
THE NATIONAL COALITION FOR CANCER SURVIVORSHIP (NCCS) presented its second annual Ellen L. Stovall Award for Innovation in Patient-Centered Cancer Care recently in Washington, DC. This year’s award recipients were Pat Coyne, MSN, of the Medical University of South Carolina, and Meg Gaines, JD, of...
Fox Chase Cancer Center Receives Historic Gift to Establish Pancreatic Cancer Institute
PHILADELPHIA PHILANTHROPIST Concetta “Chet” Greenberg has made a transformational gift to create The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. This multimillion-dollar commitment will significantly accelerate the pace of pancreatic cancer research, and...
UCLA Researchers Awarded $1M Grant to Advance Prostate Cancer Research
UNIVERSITY OF CALIFORNIA at Los Angeles (UCLA) researchers Johannes Czernin, MD, and Caius Radu, MD, have been awarded a 2017 Challenge Award from the Prostate Cancer Foundation to fund their preclinical studies and clinical trials testing the efficacy of 177-Lu-PSMA-617, a novel radiation-emitting ...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
Long-Term Survival Rates More Than Double Previous Estimates for Locally Advanced Lung Cancer
THE LONG-TERM RESULTS of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non–small cell lung cancer (NSCLC) may be more than twice as high as previous estimates, setting a new benchmark of survival for patients with...
Study Finds More Patients Treated for and Surviving Early-Stage NSCLC
WITH THE ADVANCEMENT of surgical and radiation therapy strategies for stage I non–small cell lung cancer (NSCLC), more patients are being treated, resulting in higher survival rates, according to a study published online in The Annals of Thoracic Surgery.1 “More and more patients are being cured...
Dacomitinib vs Gefitinib in Advanced NSCLC: Improving Upon Established First-Line Targeted Therapy
THE RESULTS FROM the ARCHER 1050 study—reported by Wu et al1 and reviewed in this issue of The ASCO Post—highlight the recent optimism about improved outcomes in metastatic non–small cell lung cancer (NSCLC) harboring mutations in the epidermal growth factor receptor (EGFR) gene. This trial...
New Editor-in-Chief Named to Annals of Surgical Oncology
THE SOCIETY OF SURGICAL ONCOLOGY has announced Kelly M. McMasters, MD, PhD, will assume the role of Editor-in-Chief of Annals of Surgical Oncology, effective March 2018. Dr. McMasters will oversee the print and online editions of the journal and, with Mark Roh, MD, Executive Editor, will lead the...
National Academy of Medicine Elects 80 New Members
THE NATIONAL ACADEMY OF MEDICINE announced the election of 70 regular members and 10 international members during its annual meeting in October. Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated...
ASCO Cites Evidence That Alcohol Is Linked to Cancer, Calls for Reduced Alcohol Consumption
Alcohol use—whether light, moderate, or heavy—is linked with increasing the risk of several leading cancers, including those of the breast, colon, esophagus, and head and neck, according to evidence gathered by ASCO. In a statement released November 7 identifying alcohol as a definite...
Jenske Geerling, NP, on Painful Bone Metastases: Study Results on Nurse-Led Pain Education
Jenske Geerling, NP, of the University Medical Center Groningen, discusses findings from a multicenter trial on patient education, pain reduction, and quality of life (Abstract 203).
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
Hospital Emergency Department Practices for Treating Older Adults With Cancer
A new study published by Lipitz-Snyderman et al in JNCCN–Journal of the National Comprehensive Cancer Network found that among patients presenting to the emergency department, those with cancer, especially those aged 75 years or older, are more likely to be admitted to the hospital—and...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of...
Norman E. Sharpless, MD, Sworn in as Director of the National Cancer Institute
Norman E. “Ned” Sharpless, MD, took the oath of office late Tuesday, October 17, 2017, to become the 15th Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). He succeeds Harold E. Varmus, MD, who stepped down as Director in March 2015. Douglas R. Lowy, ...
2017 Palliative Care in Oncology Symposium
The 2017 Palliative Care in Oncology Symposium took place October 27–28 in San Diego. Photos shown here, from left to right, as follows: 1. Eduardo Bruera, MD, of The University of Texas MD Anderson Cancer Center leads a group of attendees on a poster walk and discussion; 2. Charles Loprinzi, MD,...
How Effective Communication Is Integral to Patient-Centered Care
Communicating effectively with patients with advanced cancer not only helps patients and their family members successfully transition to palliative and end-of-life care, it can prevent physicians from experiencing professional burnout, according to Robert M. Arnold, MD, Distinguished Service...
First ESMO Award for Immuno-Oncology Presented to Laurence Zitvogel, MD, PhD
The European Society for Medical Oncology (ESMO) has granted the newly established ESMO Award for Immuno-Oncology to Laurence Zitvogel, MD, PhD, for her innovating and internationally recognized achievements in the field. Dr. Zitvogel is Professor of Immunobiology at the University of Paris XI...
International Trials Reveal New Findings in the Management of Breast and Ovarian Cancers
The European Society for Medical Oncology (ESMO) 2017 Congress, held in Madrid, featured important news including at least seven practice-changing or potentially practice-changing trials, which are covered in recent issues of The ASCO Post. Here we present additional highlights of studies in breast ...
Quick Takes on Studies in Noncolorectal Gastrointestinal Cancers
In this roundup, The ASCO Post offers a glance at key findings from studies in noncolorectal gastrointestinal malignancies presented at the European Society for Medical Oncology (ESMO) 2017 Congress from investigators around the world. Docetaxel-Based Triplet in Gastric Cancer The superiority of...
FDA Approves Novel Therapies for Lymphoma Indications
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a...
CHEST 2017: American College of Chest Physicians Unveils New Lung Cancer Screening Guidelines
Low-dose computed tomography (CT) screening for lung cancer has become standard practice, mostly due to the results of the National Lung Screening Trial. Related evidence continues to evolve, informing the benefits and risks of low-dose CT in clinical practice. Mazzone et al presented new ...
CHEST 2017: Gender, Language, and Treatment Setting as Barriers in Screening and Patient Care in Lung Cancer
Two new studies from CHEST 2017, held recently in Toronto, reveal disparities in lung cancer screening and care that may impact detection as well as mortality and survival rates in the disease. Risk Status and Screening The first study from Lahey Hospital and Medical Center in Burlington,...
ENDEAVOR Trial Endeavors to Make Case for Carfilzomib: Despite Survival Advantage, Should We Be Surprised?
LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...
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...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
The Liver Meeting: Daily Aspirin May Reduce Risk for Hepatitis B Virus–Related Liver Cancer
A new study presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases, found that daily aspirin therapy was significantly associated with a reduced risk in hepatitis B virus (HBV)–related liver cancer (Abstract 223). According to AASLD’s...
