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Showing 3201 - 3250Enzalutamide in Metastatic Castration-Resistant Prostate 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 September 10, 2014, the androgen receptor inhibitor...
Louis J. DeGennaro, PhD, Named President and Chief Executive Officer of The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society has announced that Louis J. DeGennaro, PhD, has been appointed as President and Chief Executive Officer, effective immediately. “Dr. DeGennaro has tirelessly dedicated himself for almost a decade of service to the Leukemia & Lymphoma Society mission and to...
ASCO, AACR Urge FDA to Regulate All Tobacco Products—Including E-Cigarettes
ASCO and the American Association for Cancer Research (AACR) sent a joint letter to the U.S. Food and Drug Administration (FDA) urging the agency to regulate electronic cigarettes, cigars, and all other tobacco products and to strengthen the proposed regulations for newly deemed products. The...
Advanced Robotic Technology Used to Remove Kidney Tumor in First-Time Outpatient Procedure
Keck Medical Center of the University of Southern California (USC) has become the first medical center in the world to use a new robotic technology in an outpatient procedure for a patient with kidney cancer. Urologic surgeons at the USC Institute of Urology, part of Keck Medicine of USC, used a...
Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer
The U.S. Food and Drug Administration has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit ...
Pathologic Complete Response: Understanding the Subtleties
In the neoadjuvant treatment of breast cancer, the importance of achieving a pathologic complete response (pCR) varies substantially by breast cancer subtype. Patients are increasingly interested in this outcome, but it means different things to different patients, according to two breast cancer...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation ...
Exciting Highlights in Several Types of Lymphoma Presented at Best of ASCO
Antibody-drug conjugates are being tested against several types of lymphomas and for some of these agents, “activity is quite impressive,” Andrew M. Evens, DO, MSc, reported at the recent Best of ASCO meeting in Chicago. Dr. Evens, Professor of Medicine, Chief, Division of Hematology/Oncology, and...
Tough Questions About Health-Care Reform Put Economist in Hot Seat
Although diverse stakeholders agree that health reform is needed, there is little consensus on the specifics of that reform. Best of ASCO Seattle attendees put a number of pointed questions to health economist Rena Conti, PhD, of the University of Chicago, asking about thorny issues such as cost...
Health-Care Reform Is Changing the Oncology Landscape
Value-based health-care reform is happening. We have to get on board,” Rena Conti, PhD, a health economist at the University of Chicago, advised attendees of the Best of ASCO Seattle meeting. She discussed highlights from Annual Meeting sessions that addressed the impact of the Affordable Care Act...
Lenvatinib Receives Priority Review Designation for Advanced Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has given Priority Review designation to the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer. Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a...
E-Cigarettes Unhelpful in Smoking Cessation Among Patients With Cancer
In a new study of patients with cancer who smoke, those using e-cigarettes in addition to traditional cigarettes were more nicotine-dependent and equally or less likely to have quit smoking traditional cigarettes than nonusers.1 The rising use of e-cigarettes has raised many questions among...
Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the FDA granted ...
FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) has approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron, which ...
FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was...
Novel Agents May Address Endocrine Therapy Resistance
Progress has recently been swift in the development of new drugs to improve the response to hormone therapy in breast cancer, according to Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen...
Recent Reports and Perspectives on Chronic Lymphocytic Leukemia
Recent articles on developments and controversies in the treatment of chronic lymphocytic leukemia include the following features from The ASCO Post, which are also available at www.ascopost.com: “Recent FDA Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare ...
Expect Questions About Pertuzumab for HER2-Positive Breast Cancer
The 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the CLEOPATRA trial represents a 15.7-month survival advantage for those receiving pertuzumab...
Impressive Survival Data for Women With HER2-Positive Breast Cancer Increase First-Line Use of Pertuzumab/Trastuzumab
"Impressive,” “outstanding,” and “unprecedented” are among the terms used to describe the 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the...
Ramucirumab in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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 November 5, 2014, ramucirumab (Cyramza) was approved for use...
ASCO Endorses CAP/IASLC/AMP Guidelines for Molecular Testing of Patients With Non–Small Cell Lung Cancer
Personalized medicine is an established treatment concept for patients with advanced non–small cell lung cancer (NSCLC), and molecular characterization of tumors is crucial for choice of (first-line) therapy. As of right now, we have U.S. Food and Drug Administration (FDA)-approved drugs for two...
BRAF/MEK Inhibition in BRAF-Mutant Advanced Melanoma
Preliminary evidence of efficacy for BRAF inhibitors as monotherapy in advanced melanoma first emerged in 2009.1 Phase II and III trials rapidly ensued for vemurafenib (Zelboraf) and dabrafenib (Tafinlar), leading to U.S. Food and Drug Administration (FDA) approval in 2011. As a result of melanoma...
Expert Panel Explores Cost, Value, and Patient-Centered Care in Cancer Treatment
In assessing a cancer treatment, cost and value are two key factors. So how, the moderator asked, do they enter into your everyday decisions? Tanisha Carino, PhD, Executive Vice President of Avalere Health, was speaking to a clinical oncologist, a patient advocate, a pharma executive, and a health...
Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing
At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...
Initiative 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...
