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Showing 3251 - 3300Initiative Aims to Accelerate Development of Targeted Therapies for Multiple Myeloma
Multiple Myeloma Research Foundation (MMRF) has announced an initiative designed to accelerate the evaluation of new investigational therapies for multiple myeloma. The MMRF, in collaboration with the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), pharmaceutical,...
NIH Awards Aim to Improve Understanding of Cell Pathways, Development of New Therapies
Building on a successful 3-year pilot project, the National Institutes of Health (NIH) has awarded more than $64 million to six individuals at five research institutions to create a database of human cellular responses—the Library of Integrated Network-based Cellular Signatures (LINCS)....
Fixed-Combination Netupitant/Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting
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 October 10, 2014, oral fixed-combination netupitant and...
FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of...
Top 10 Myths About FDA’s Office of Hematology and Oncology Products
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...
Bortezomib in Previously Untreated 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. On October 9, 2014, bortezomib (Velcade) was granted approval for ...
Emerging Drugs Effectively Tackle Non–Small Cell Lung Cancer Mutations
For advanced nonsquamous non–small cell lung cancer (NSCLC), targeting of the epidermal growth factor receptor (EGFR) mutation and the ALK abnormality has become an established strategy. Later-generation drugs in these categories are now showing efficacy in trials, including for the treatment of...
FDA Approves Labeling With Abuse-Deterrent Features for Extended-Release Opioid Analgesic
The U.S. Food and Drug Administration (FDA) has approved new labeling for morphine sulfate and naltrexone hydrochloride extended-release capsules. The drug, marketed as Embeda, is an opioid analgesic used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and ...
FDA Grants Breakthrough Therapy Designation Pembrolizumab in Advanced Non–Small Cell Lung Cancer
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway–mediated inhibition of the immune response,...
Magee-Womens Hospital of UPMC Offers Test to Predict Possibility of Breast Cancer Recurrence
Magee-Womens Hospital of University of Pittsburgh is offering its patients the FDA-cleared breast cancer test assessing a woman’s risk of cancer recurrence by providing a risk category and numerical score. The hospital is the first in the tri-state area (Pennsylvania, Ohio, West Virginia) to offer...
Raising Consciousness About Drug Costs: A Call to Action
As medical oncologists working in chemotherapy utilization management (Oncology Analytics, Inc), my colleagues and I find ourselves daily in the center of the drug-cost maelstrom. While it is encouraging to see that more attention is being paid in the popular and medical press to this...
Yale Cancer Center’s Dr. Susan Mayne Appointed to FDA Position
Susan T. Mayne, PhD, C-EA, Winslow Professor of Epidemiology; Associate Director for Population Sciences at Yale Cancer Center; and Chair of the Department of Chronic Disease Epidemiology at Yale School of Public Health, has been appointed to the position of Center Director of the Center for Food...
FDA Approves Extended-Release, Single-Entity Hydrocodone Product With Abuse-Deterrent Properties
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate (Hysingla ER), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product...
Focused Ultrasound, a Young Technology, Begins to Grow
In the United States, it’s been a good 2 years for focused ultrasound. The technology, which uses multiple, intersecting ultrasound beams to treat cancer and other diseases, completed its first successful U.S. phase III oncology trial—to alleviate the pain of bone metastases—and received approval...
From ‘Clinical Judgment’ to Evidence-Based Medicine: Thoughts on the ASCO/CCO Guideline in Metastatic Castration-Resistant Prostate Cancer
We are witnessing unprecedented progress in the development of therapy for patients with metastatic castration-resistant prostate cancer. The U.S. Food and Drug Administration (FDA) has issued 13 approvals since 1996 for agents that have demonstrated an impact on overall survival, pain, or...
FDA Grants Orphan Drug Designation to BGB324 for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BGB324 for the treatment of acute myeloid leukemia (AML). BGB324 is a first-in-class, highly selective small-molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition...
Top 5 Breakthroughs in the Treatment of Advanced Lung Cancer
A countdown of the top 5 breakthrough therapies in the treatment of advanced lung cancer was presented by D. Ross Camidge, MD, PhD, at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.1 Dr. Camidge is Director, Thoracic Oncology Clinical and Clinical Research Programs, and...
FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer
The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approval is ...
New Agents and Novel Targets for Multiple Myeloma
New therapies for multiple myeloma have dramatically improved life expectancy, but despite these advances, 5-year overall survival still remains below 50%. Investigators are in hot pursuit of new therapies that will extend remissions and improve survival. Thus far, monoclonal antibodies,...
CancerLinQ: Building a Data Infrastructure to Improve Quality and Reduce Cost
In November 2013, ASCO initiated the development of CancerLinQ, a learning health system designed to transform cancer care and improve outcomes. At this year’s Quality Care Symposium in Boston, ASCO President Peter Paul Yu, MD, FACP, FASCO, Director of Cancer Research at the Palo Alto Medical...
FDA Approves Ruxolitinib to Treat Patients With Polycythemia Vera
The U.S. Food and Drug Administration (FDA) approved a new use for ruxolitinib (Jakafi) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Ruxolitinib, a JAK inhibitor, is the first drug approved by the FDA for this condition. Polycythemia vera occurs when too many red ...
Top 10 Articles From The ASCO Post in 2014
The following list presents those articles published in 2014 that were observed most often by visitors to ASCOPost.com, as measured by the number of views.a To view the full version of the articles listed below, visit ASCOPost.com and enter the URL provided below each entry. 1. Continuous...
Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib as a first-line treatment in combination with paclitaxel and gemcitabine in patients with metastatic pancreatic cancer. Necuparanib is a novel oncology drug candidate engineered from...
FDA Approves Blinatumomab to Treat Rare Form of Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to blinatumomab (Blincyto) for the treatment of patients with Philadelphia chromosome–negative, relapsed or refractory precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blinatumomab is a bispecific...
FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was...
Ixazomib Receives Breakthrough Therapy Designation for Relapsed or Refractory Systemic Light-Chain Amyloidosis
The U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy status to Takeda Pharmaceuticals’ investigational, oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain amyloidosis. This is the first proteasome inhibitor and...
FDA Guidance on the Use of Pathologic Complete Response in Development of New Treatments for High-Risk Early Breast Cancer Includes ASCO Suggestions
The U.S. Food and Drug Administration’s (FDA) final Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer incorporates two changes that ASCO had proposed in comments submitted to the agency on a draft guidance issued in 2012. The...
Policy Issues in Molecularly Targeted Therapy: The Science, the Money, the Applications
In the past decade, much new knowledge about the molecular underpinnings of cancer has accumulated, and the array of molecular aberrations in each individual tumor can be assessed through genomic sequencing and other tests. The rationale for and feasibility of developing molecularly targeted...
Getting the Most Out of Ipilimumab in Melanoma
Ipilimumab (Yervoy) was first approved by the U.S. Food and Drug Administration (FDA) in 2011 on the basis of an improvement in overall survival compared with gp100 vaccine in patients with advanced melanoma.1 Response rates with ipilimumab have been modest at best—10% to 15% using 3 mg/kg and 15%...
Lung Cancer: Next Frontier for Immunotherapy
Immune checkpoint inhibitors, particularly PD-1 (programmed cell death-1) and PD-L1 (programmed death-ligand 1) inhibitors, are being studied extensively in lung cancer. These agents, alone and in combination, appear to have the potential to change the management of non–small cell lung cancer...
FDA Approves Denosumab for the Treatment of Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
The U.S. Food and Drug Administration has approved a new indication for denosumab (Xgeva) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Denosumab was approved and granted Orphan Drug designation by the FDA, which is reserved for drugs that are intended for...
Olaparib for BRCA-Mutated Previously Treated Advanced Ovarian Cancer
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 December 19, 2014, olaparib (Lynparza) was granted accelerated...
Smarter Trial Design Saves Money and Produces Better Drugs
The process of identifying a promising molecule and moving it from the laboratory through the highly complex series of clinical trials necessary to garner U.S. Food and Drug Administration (FDA) approval is a costly scientific gauntlet during which many new agents fail. New trial design,...
Gardasil 9 Adds Protection Against Cancer Caused by Additional Human Papillomavirus Types
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 December 10, 2014, Gardasil 9 (human papillomavirus 9-valent...
FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer
The recent U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. The BRCA...
Lanreotide in Gastroenteropancreatic Neuroendocrine Tumors
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 December 16, 2014, lanreotide (Somatuline depot injection) was ...
Top 10 Myths About FDA’s Office of Hematology and Oncology Products
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...
Anti–PD-1 Antibody Nivolumab in Previously Treated Unresectable or Metastatic Melanoma
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 December 22, 2014, the anti–PD-1 (programmed cell death...
FDA Drug Approvals 2014
Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma. Approved December 22, 2014. Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014....
FDA’s Janet Woodcock, MD, Receives Lifetime Achievement Award From the Institute for Safe Medication Practices
Janet Woodcock, MD, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, has been awarded the Institute for Safe Medication Practices Lifetime Achievement Award, which recognizes “an individual who has had a significant career history of making...
ASCO and AACR Call for Regulation of E-Cigarettes and Other Electronic Nicotine Delivery Systems
The American Association for Cancer Research (AACR) and ASCO have outlined steps in a joint statement to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems without undermining their...
FDA’s Draft Guidance for Laboratory-Developed Tests
The FDA’s proposed regulatory framework is based on a test’s level of risk to the patient. Premarket approvals would be required of the tests in the highest-risk category within a year of the final guidance; that would include tests for which there is already an FDA-approved equivalent. For...
Molecular Pathologists vs the FDA: Proposed Regulation of Laboratory-Developed Tests Sparks Debate
The packed ballroom looked like a plenary session at any big medical research meeting. But on the dais were representatives of the Food and Drug Administration (FDA), the subject was the Agency’s proposed regulation of laboratory-developed tests, and the attendees who lined up to ask questions for...
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three...
FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...
FDA Approves Nivolumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been...
Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research
Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...
Supplemental 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...
CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine:daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia. The FDA established the Fast...
Ramucirumab in Metastatic Non–Small Cell Lung Cancer
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. In December 12, 2014, ramucirumab (Cyramza) was approved for use in ...
