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Showing 3101 - 3150Sorafenib in Differentiated Thyroid Carcinoma
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. New Indication On November 22, 2013, sorafenib (Nexavar) was...
ASCO, AACR, and Campaign for Tobacco-Free Kids Urge FDA Prohibition of Menthol Cigarettes
ASCO has sent joint letters with both the American Association for Cancer Research (AACR) and the Campaign for Tobacco-Free Kids (CTFK) to the Food and Drug Administration (FDA) urging that the agency establish regulations to eliminate menthol in cigarettes. The agency is currently considering...
Molecularly Targeted Therapy for Lung Cancer
INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new...
Philips Receives FDA Clearance for Spectral Breast Density Measurement Application
Royal Philips has announced that that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Spectral Breast Density Management Application for its MicroDose SI full-field digital mammography system. The application is the first spectral breast density measurement ...
Novel BRAF Fusions Identified in 'Pan-Negative' Melanomas Subset May Be Sensitive to MEK Inhibition
A study by Sosman et al has identified two novel BRAF fusions in melanomas previously considered to be negative for molecular targets. In addition, these “pan-negative” melanomas were found to be sensitive to MEK inhibitors. According to the study, BRAF fusions define a new molecular subset of...
Health IT Safety Guide
A new set of guides and interactive tools to help health-care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at www.HealthIT.gov. The Office of the National Coordinator for Health Information Technology (ONC)...
FDA Approves Combination Therapy for Unresectable or Metastatic Melanoma With BRAF V600E/K Mutations
The U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) for use in combination with dabrafenib (Tafinlar) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved...
Dabrafenib Receives FDA Breakthrough Therapy Designation for BRAF-Mutated NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) for the treatment of patients with metastatic BRAF V600E mutation–positive non–small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing...
Cancer Genes, Promiscuity, and the National Debt
There is no doubt that this is a halcyon period in oncology. The unraveling of the genome has been tremendously important, and finally has helped us to move treatment selection from an era of rational empiricism to one of refined, molecular prognostication. In the care of breast cancer, the impact...
An Early Chemotherapy Innovator, Franco M. Muggia, MD, Now Focuses on Advancing Therapies for Ovarian Cancer
Looking over an illustrious career in medical oncology that spans 5 decades, Franco M. Muggia, MD, told The ASCO Post that he is excited about the future and hopes to continue making contributions to the field of oncology in years to come. At the forefront of the early clinical development of...
FDA Programs to Expedite Drug and Biologic Product Development
With the advent of Breakthrough Therapy designation, there are now four FDA programs to expedite the development of promising new agents: Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval (Table 1). These programs complement one another and serve a common goal: to speed...
Trametinib and Dabrafenib in Combination for Unresectable or Metastatic Melanoma With BRAF V600E or V600K Mutations
On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved...
ASCO and College of American Pathologists Guideline Update: Recommendations for HER2 Testing in Breast Cancer
The American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) recently convened an Update Committee to conduct a systematic literature review and update recommendations for optimal HER2 testing. In particular, the Committee identified criteria and areas requiring...
FDA Approves CliniMACS CD34 Reagent System for the Prevention of Graft-vs-Host Disease in AML
The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell...
FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of...
FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously granted...
ASCO Supports Reinforcing FDA Capacity to Monitor Nation’s Drug Supply
“The GAO report identifies production lapses due to quality problems and constrained manufacturing capacity as being the central causes of the widespread incidence and persistence of drug shortages. “The report also emphasizes that the FDA has made significant progress in preventing shortages by ...
U.S. Government Accountability Office Issues Report on Drug Shortages
The U.S. Government Accountability Office (GAO) recently issued a report evaluating drug shortages and the associated public health threats, including prolonged duration of a disease, permanent injury, and death.1 This report follows a recommendation by GAO in 2011 that the U.S. Food and Drug...
PREVAIL Trial Shows Enzalutamide to Be a Promising Option for Metastatic Castration-Resistant Prostate Cancer
Encouraging results of the large phase III PREVAIL trial represent another positive milestone for men with metastatic castration-resistant prostate cancer. Enzalutamide (Xtandi) improved overall survival by 29% and reduced the risk of radiographic progression of disease by 81% in men who had not...
Cancer Genes and Molecular Medicine: More Education Needed
I read with interest and concern the Perspective piece, “Cancer Genes, Promiscuity, and the National Debt,” which appeared on page 1 of the February 1st issue of The ASCO Post. The underlying premise of this wide-ranging and provocative article would appear to be that in a rush to implement...
Major Cancer Milestones in History, From ASCO’s CancerProgress.Net
To help tell the story of progress against cancer, ASCO launched CancerProgress.Net in 2011. The site is intended as a resource for media, policymakers, oncologists, advocates, and the public. One central feature of the site is an interactive timeline of major milestones in cancer treatment,...
Neuro-Oncology Community Convenes in Workshop to Advance Imaging-Related Endpoints in Clinical Trials
Leaders from key cross-sections of the neuro-oncology community came together at a recent Brain Tumor Clinical Trial Endpoints Workshop to confront a critical challenge in developing and testing treatments for glioblastoma multiforme. Participants were able to adjourn the workshop with the...
Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia
On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell...
FDA Orders Cessation of Sale, Distribution of Four Tobacco Products
FDA has issued orders to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco...
FDA Grants Orphan Drug Status to Pracinostat for the Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational drug pracinostat for the treatment of acute myeloid leukemia (AML). The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective...
Omacetaxine Mepesuccinate Receives Full FDA Approval for CML
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...
Expert Point of View: Anas Younes, MD
This study provides proof of principle that different tumor types that express CD30 have a good chance of responding to anti-CD30 treatment. Brentuximab achieves good response rates of about 76% in mycosis fungoides and 85% in [anaplastic T-cell lymphoma]. In [mycosis fungoides] and cutaneous...
Promising Results Demonstrated for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
Phase II results suggest that brentuximab vedotin (Adcetris) has encouraging activity in CD30-positive cutaneous T-cell lymphomas and lymphoproliferative disorders, including mycosis fungoides, the most common type of cutaneous T-cell lymphoma. High levels of responses were achieved in a 48-patient ...
The Evolution of U.S. Cooperative Group Trials: Publicly Funded Cancer Research at a Crossroads
Over the past 5 decades, National Cancer Institute (NCI) Clinical Trials Cooperative Groups have played an enormous role in the fight against cancer, tackling a broad social agenda, including cancer prevention, quality-of-life issues for patients with cancer, and comparison of benefits among...
The FDA’s Bad Ad Program
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The...
Shaw T. Chen, MD, PhD, Joins Polaris Pharmaceuticals
Shaw T. Chen, MD, PhD, has been appointed Executive Vice-President of Regulatory Affairs at Polaris Pharmaceuticals, a subsidiary of Polaris Group. Dr. Chen had previously been with the U.S. Food & Drug Administration (FDA) for over 26 years in new drug development. Most recently he served as...
Study Shows Pathologic Complete Response to Neoadjuvant Therapy for Breast Cancer of Prognostic Value but Not for Use as Surrogate for Survival
Pathologic complete response to neoadjuvant therapy has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) working group to...
Electronic Cigarette Use and Smoking Among Adolescents
Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among U.S. adolescents.” This was the conclusion of a cross-sectional analysis of survey data from a representative sample of middle and high school students who completed the National Youth Tobacco Survey (NYTS) ...
A Conversation With Arie Belldegrun, MD, FACS, and Allan Pantuck, MD, MS, FACS
Cancer Immunotherapy What is the role of immunotherapy in the treatment of metastatic renal cell carcinoma? The harnessing of the immune system as an effective treatment for cancer was recently selected by the journal Science as the top scientific Breakthrough of the Year for 2013.1 With this...
Ethiodized Oil Approved for Imaging of Hepatocellular Carcinoma Tumors
The U.S. Food and Drug Administration has approved ethiodized oil injection (Lipiodol) for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma. The agent received orphan drug designation for management of patients with known hepatocellular carcinoma ...
FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The...
FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product
Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the...
PALOMA-1 Trial Finds Palbociclib/Letrozole Doubles Progression-Free Survival in Metastatic Breast Cancer
First-line treatment with the combination of palbociclib plus letrozole extended progression-free survival by approximately 50% in patients with metastatic estrogen receptor–positive, HER2-negative breast cancer, according to final results of the PALOMA-1 trial, a randomized phase II study...
Learning More About Expanded Access Programs
The FDA and ASCO have collaborated to create an educational webinar to explain expanded access programs and to clarify the process to access investigational drugs outside a clinical trial. Although it is primarily intended for physicians, the webinar provides valuable information to anyone...
Quality Cancer Care
Ten years ago, at ASCO’s Annual Meeting, we were celebrating 40 Years of Quality Cancer Care. We have certainly seen many improvements in cancer care quality since then, especially in more effective agents and patient-centeredness care. When I joined ASCO in 1984, I never imagined that I would be...
SIDEBAR: FDA-Approved Drugs to Use as Single Agents or in Combination Chemotherapy
2014 Ceritinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic NSCLC with disease progression on or who are intolerant to crizotinib; mercaptopurine as a 20 mg/mL oral suspension for the treatment of acute lymphoblastic leukemia as part of a combination...
The Leukemia & Lymphoma Society Surpasses $1 Billion Investment in Blood Cancer Research
The Leukemia & Lymphoma Society (LLS) has announced that it has passed the $1 billion mark in research investment, a significant milestone in the cancer research landscape as the Society continues its 65-year pursuit of advancing breakthrough therapies, finding cures, and ensuring access to...
Ramucirumab for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
On April 21, 2014, ramucirumab (Cyramza) was approved for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing...
James P. Allison, PhD, Receives 2014 Canada Gairdner International Award
The Gairdner Foundation of Canada has named James P. Allison, PhD, for one of its 2014 Canada Gairdner International Awards. Dr. Allison is Chair and Professor of Immunology at The University of Texas MD Anderson Cancer Center in Houston. The honor, announced recently by the Gairdner Foundation,...
Project Data Sphere: Megadata in the Cloud Could Speed Clinical Trials Here on Earth
Project Data Sphere, which launched on April 8, is a “giant digital laboratory, an enormous library containing data about tens of thousands of patients and hundreds of clinical trials, all of which will be in the public domain,” said Martin J. Murphy, Jr, DMedSc, PhD, FASCO, Chief Executive Officer ...
Michael S. Gordon, MD, Named Medical Director for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare
Michael S. Gordon, MD, has been named the new Medical Director for the Virginia G. Piper Cancer Center Clinical Trials program at Scottsdale Healthcare in Phoenix. Dr. Gordon will oversee the center’s phase I clinical trials program. Virginia G. Piper Cancer Center Clinical Trials at Scottsdale...
FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids
In a safety communication notice issued recently, the U.S. Food and Drug Administration (FDA) discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it...
Demanding More From Clinical Trials
“The function of the formal controlled clinical trial is to separate the relative handful of discoveries that prove to be true advances in therapy from a legion of false leads and unverifiable clinical impressions, and to delineate in a scientific way the extent of and the limitations that attend...
Cancer Chemotherapy Use During Pregnancy
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, National Toxicology Program scientists Kembra L. Howdeshell, PhD, and Michael D. Shelby, PhD, discuss a recently completed monograph that reviews the published data on...
Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for...
