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Showing 3051 - 3100Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule...
Cediranib Achieves 'Groundbreaking' Results in Relapsed Ovarian Cancer
The investigational oral vascular endothelial growth factor (VEGF) inhibitor cediranib extended progression-free survival when given with platinum-based chemotherapy and improved overall survival when given as maintenance therapy in patients with recurrent ovarian cancer. Experts are hopeful that...
Strong Showing for Ado-Trastuzumab Emtansine in Advanced HER2-Positive Heavily Pretreated Breast Cancer
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab emtansine (Kadcyla), formerly known as T-DM1, extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including...
FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for...
New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
Has a New Standard of Care for Metastatic Pancreatic Cancer Been Established?
For a number of years following the approval of gemcitabine for advanced pancreatic cancer, one phase III clinical trial after the next failed to demonstrate a survival benefit of combination chemotherapy compared to gemcitabine alone. Even the one positive study from the mid-2000s—the PA.3 trial...
SIDEBAR: FDA Drug Approvals, 2013
Ibrutinib (Imbruvica) for mantle cell lymphoma Obinutuzumab (Gazyva) for chronic lymphocytic leukemia Pertuzumab (Perjeta) for breast cancer Paclitaxel protein-bound particles (Abraxane) for pancreatic adenocarcinoma Afatinib (Gilotrif) for non-small cell lung cancer, with Therascreen EGFR...
FDA Approves Ibrutinib for Mantle Cell Lymphoma
The U.S. Food and Drug Administration has approved ibrutinib (Imbruvica) to treat patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma representing about 6% of all non-Hodgkin lymphoma cases in the United States. By the time mantle cell lymphoma is diagnosed, it...
Early Evidence Supports Novel ALK Inhibitor in Patients with Non–Small Cell Lung Cancer With Brain Metastases
Identifying ALK rearrangements as a cancer target in patients with lung cancer led to the development and FDA approval of crizotinib (Xalkori) to treat ALK-positive non–small cell lung cancer (NSCLC). Several second-generation ALK inhibitors are in development, and these agents appear to work in...
Response-Guided Neoadjuvant Therapy for Breast Cancer: A Promising Model Warranting Additional Investigation
GeparTrio was an innovative phase III trial conducted by the German Breast Group, enrolling over 2,000 women with early breast cancer who were candidates for neoadjuvant chemotherapy. Patients with evidence of early response, defined as reduction in clinical tumor size by 50% or more, following two ...
Young Tobacco Consumers Frequently Use Products Other Than Cigarettes
“A substantial proportion of youth tobacco use occurs with products other than cigarettes, so monitoring and prevention of youth tobacco use needs to incorporate other products, including new and emerging products,” according to the Morbidity and Mortality Weekly Report, published by the Centers...
NIH Announces New Co-Chairs of Panel on Antiretroviral Guidelines
The National Institutes of Health recently announced several changes in leadership on the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. The panel, a working group of the NIH Office of AIDS Research Advisory Committee (OARAC), consists of...
Ibrutinib in Previously Treated Mantle Cell Lymphoma
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. Indication On November 13, 2013, ibrutinib (Imbruvica) was granted...
The Quest to Optimize Personalized Therapies for Cancer
In the late 1980s, Brian J. Druker, MD, was investigating the BCR-ABL tyrosine kinase as a target for therapeutic intervention for chronic myeloid leukemia (CML) in a laboratory at Dana-Farber Cancer Institute in Boston. By 1993, Dr. Druker had moved to Oregon Health & Science University in...
National Cancer Policy Summit: Setting Priorities for the Next 3 Years
Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...
FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted regular approval for crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval was based...
FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer
The U.S. Food and Drug Administration recently expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to...
Oncology Drug Dosing: Can an Optimal Dose Be Fine-Tuned for Each Patient?
ASCO Chief Medical Officer Richard L. Schilsky, MD, and other oncology drug experts presented a panel on drug dosing at a recent meeting, cosponsored by the Friends of Cancer Research and the Brookings Institution, in Washington, DC.1 The presentations made it clear that issues surrounding drug...
Clinical Cancer Advances 2013: ASCO's Annual Report on Progress Against Cancer
The Society has recently published Clinical Cancer Advances 2013: ASCO’s Annual Report on Progress Against Cancer, a comprehensive review of progress in clinical cancer research that has come to fruition in 2013. The report highlights advances across the entire continuum of cancer care, from...
Correctly Assessing Pain Progression and Quality-of-Life Deterioration in Metastatic Castration-Resistant Prostate Cancer
The therapeutic landscape for the treatment of castration-resistant prostate cancer has changed dramatically in the past 4 years, as five new agents affecting different aspects of the malignant process were proven to prolong life. The results are a great benefit to patients, but at the same time...
Breast Cancer Vaccines for Primary Prevention Move Toward Clinical Use
The first candidate vaccine to prevent recurrence of breast cancer entered clinical trials about 8 years ago, and since then, the idea of a vaccine for secondary prevention has gained traction; more such vaccines are now in development. But this fall, it was vaccines for primary prevention that had ...
Expert Point of View: Howard Hochster, MD
Addressing a presentation by Scott Kopetz, MD, PhD, at the 2013 Chemotherapy Foundation, Howard Hochster, MD, Yale University Cancer Center, New Haven, Connecticut, said he agrees with Dr. Kopetz about the need for expanded RAS testing. “Now we have two studies suggesting that tumors with all the...
Using Hyperthermia for Cancer Treatment: Proofs, Promises, and Uncertainties
With the headline, “Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny,” a recent article in The New York Times reported that several medical centers were treating patients with cancer using a hyperthermia system that had received a Humanitarian Use Device approval from the U.S....
Activation of Innovative Lung Cancer Master Protocol Officially Announced, Enrollment to Begin in March
At a recent meeting in Washington, DC, Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution officially announced activation of the Lung Cancer Master Protocol, a new research strategy that has the potential to hurdle or bypass known clinical trial...
Sorafenib 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...
