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Showing 2601 - 2650Drug Prices and Value: Finding Middle Ground
The advent of targeted therapies along with complex personalized treatment regimens has added many effective tools to the oncology armamentarium. But progress has a price tag. Although the oncology community needs new drugs, there is growing concern that the price of many newer compounds is...
DigniCap Scalp-Cooling System Now Available for Women With Breast Cancer at 10 U.S. Cancer Treatment Centers
Dignitana Inc. recently announced that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment...
AACR 2016: Comparison of Three Different PD-L1 NSCLC Diagnostic Tests Shows a High Degree of Concordance
Three commercially available diagnostic tests were similarly effective in measuring programmed death ligand 1 (PD-L1) protein expression on non–small cell lung cancer (NSCLC) tumor samples, indicating that health-care providers may someday be able to use these tests interchangeably when...
AACR 2016: LOXO-101 Shows Continued Promise in Patients Whose Tumors Had NTRK Gene Fusions
The investigational drug LOXO-101, which selectively targets a family of proteins called neurotrophic tyrosine kinase receptors (NTRKs), produced significant tumor regression in patients whose tumors had NTRK gene fusions, according to data from a phase I clinical trial presented by Hong et al at...
FDA Accepts Supplemental Biologics License Application for Nivolumab in Classical Hodgkin Lymphoma, Grants Priority Review
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of nivolumab (Opdivo) to patients with classical Hodgkin lymphoma after prior therapies. The application...
FDA Accepts Supplemental Biologics License Application for Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer, Grants Priority Review
Merck today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), a monoclonal antibody and anti–programmed cell death 1 (PD-1) therapy, for the treatment of...
FDA Approves Venetoclax for Chronic Lymphocytic Leukemia With 17p Deletion
On April 11, 2016, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venetoclax is the first...
A Political Activist Challenges the Drug Approval Process and the U.S. Government
The U.S. Food and Drug Administration’s (FDA’s) primary concern in the drug approval process is to ensure that the drug is safe and effective. For the past several decades, the advocacy groups have vociferously painted the agency as a stodgy bureaucracy that prevents desperate patients access to...
FDA Approves Defibrotide for Complication of Stem Cell Transplant
On March 30, 2016, the U.S. Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic...
FDA Approves Defibrotide Sodium for the Treatment of Hepatic Veno-Occlusive Disease Following Hematopoietic Stem Cell Transplantation
On March 30, 2016, the U.S. Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic...
DigniCap Scalp Cooling System Now Available for Women With Breast Cancer at 10 U.S. Cancer Treatment Centers
Dignitana Inc. announced today that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment...
ASCO Issues Report on State of Cancer Care in America: 2016
The State of Cancer Care in America: 2016, published online in the Journal of Oncology Practice1 and presented earlier this month at a Congressional briefing in Washington, DC, is ASCO’s third annual assessment of national trends in cancer care delivery. The report highlights many promising cancer...
Introduction of New Diagnostic Devices in Oncology: New Is Not Necessarily Better
“New!” “Improved!” “Throw out that old [fill in the blank] and go buy a new [fill in the blank]!” Sound familiar? The key to marketing is to convince customers that they need a product without which they had previously been quite happy. All too often, this strategy is accompanied by a caveat emptor ...
Is This the Dawn of Cancer Biosimilars?
The Patient Protection and Affordable Care Act, signed into law in 2010, did more than make it possible for millions of Americans to afford health care; it also established an abbreviated approval pathway for biologic products that are “biosimilar” to, or shown to be “interchangeable” with, a U.S....
FDA Approves Obinutuzumab in Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva), an anti-CD-20 monoclonal antibody, for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are...
FDA Approves Everolimus for Neuroendocrine Tumors of GI or Lung Origin
The U.S. Food and Drug Administration (FDA) has approved everolimus (Afinitor), an mTOR inhibitor, for the treatment of adult patients with progressive, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal (GI) or lung origin with unresectable, locally advanced, or metastatic ...
FDA Approves Crizotinib for ROS1-Positive Metastatic Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration has approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are ...
Regulators Embrace Immunotherapy
The Cancer Drug Development Forum exists to provide, as the name implies, a meeting place to bring together academia, the pharmaceutical industry, and most important regulators for full and frank discussions to facilitate anticancer drug development. In the recent past, the Cancer Drug Development...
Anticoagulation in Patients With Cancer: Understanding the Complexities of Prophylaxis and Management
Venous thromboembolic events are more prevalent in patients with cancer than in persons without it. Cancer is associated with a high rate of venous thromboembolism recurrence, bleeding, requirement for long-term anticoagulation, and reduced quality of life. Moreover, thrombosis is the second most...
ASCO Report Finds U.S. Cancer Care System Ill-Equipped to Deliver New Advances to Patients
As the nation embarks on an ambitious “moonshot” to accelerate progress against cancer, our system for delivering today's cancer treatments must be better prepared to bring advances to all patients, warns a new report from ASCO. The State of Cancer Care in America: 2016, published...
FDA Approves Crizotinib for ROS1-Positive Metastatic NSCLC
The U.S. Food and Drug Administration today approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients...
U.S. Senate Confirms Robert M. Califf, MD, as FDA Commissioner
On February 24, 2016, Stephen Ostroff, MD, Acting Director of the U.S. Food and Drug Administration (FDA) issued a statement to announce that the U.S. Senate voted in support of the confirmation of Robert M. Califf, MD, to be Commissioner FDA. In the statement, Dr. Ostroff said, “Dr. Califf has...
ASCO Provides Support and Guidance for the White House Cancer Moonshot Initiative
Although President Richard Nixon signed the National Cancer Act in 1971, essentially declaring a war on cancer, the genesis of the idea had actually been born 2 years earlier, after the first landing on the moon set off a new era of scientific exploration and sparked a belief that any scientific...
FDA Approves Everolimus for Neuroendocrine Tumors of Gastrointestinal or Lung Origin
The U.S. Food and Drug Administration today approved everolimus (Afinitor) for the treatment of adult patients with progressive, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced, or metastatic disease. ...
FDA Approves Obinutuzumab in Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab...
ASCO Commends Confirmation of Robert M. Califf, MD, as FDA Commissioner
“We commend the U.S. Senate for confirming Robert M. Califf, MD, as Commissioner of the Food and Drug Administration (FDA). Dr. Califf brings extraordinary expertise and vision to this position and we are confident that his appointment will positively impact cancer care. “Dr. Califf's...
100% of NCI-Designated Cancer Centers Endorse the Promotion of the HPV Vaccination for Cancer Prevention
All National Cancer Institute (NCI)-designated cancer centers have united to support human papillomavirus (HPV) vaccination (see below). A team of HPV experts drafted a consensus statement that advises widespread use of HPV vaccines to prevent cancer. HPV causes cancer of the cervix, anus, and...
Mistletoe
The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and...
FDA Approves Palbociclib in Combination With Fulvestrant in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
On February 19, 2016, the U.S. Food and Drug Administration approved palbociclib (Ibrance) in combination with fulvestrant for the treatment of women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer with...
Oncology Drug Approvals: Year in Review
In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to...
Emory and Winship Announce Sagar Lonial, MD, as Hematology and Medical Oncology Department Chair
Sagar Lonial, MD, an internationally renowned expert in the biology and treatment of patients with multiple myeloma, has been named Chair of the Department of Hematology and Medical Oncology within Emory University School of Medicine and Winship Cancer Institute. Dr. Lonial assumes this role...
Management of Advanced Lung Cancer in the Elderly: A Reason to Rejoice or a Cause for Concern?
There is ample evidence to suggest that older adults with a good performance status (0 or 1) with advanced non–small cell lung cancer (NSCLC) should be treated with combination chemotherapy akin to younger patients.1,2 However, older adults comprise a heterogeneous group that has been...
Eribulin Improves Overall Survival vs Dacarbazine in Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in The Lancet, Schöffski et al found that eribulin improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received at least two prior systemic treatments for advanced disease. Outcome in the subgroup with...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
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 11, 2015, alectinib (Alecensa) was granted...
Expanded Approval of Pembrolizumab in 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 18, 2015, approval of the programmed cell death...
A Pioneering Oncologist’s Roadmap Forward
Bookmark Title: The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable—and How We Can Get There Authors: Vincent T. DeVita, Jr, MD, and Elizabeth DeVita-Raeburn Publisher: Farrar, Straus and Giroux Publication date:...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra), a CD20-directed cytolytic monoclonal antibody, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia...
Defibrotide Under Review for Transplant-Related Complication
A potentially fatal complication of hematopoietic stem cell transplantation may be reversed with the use of a novel drug currently under priority review at the U.S. Food and Drug Administration (FDA). Hepatic veno-occlusive disease/sinusoidal obstruction syndrome is usually a serious complication...
ASCO Names Cancer Advance of the Year: Immunotherapy
At a Capitol Hill briefing today, ASCO announced immunotherapy as the top cancer advance of the year. Recent breakthroughs in immunotherapy—along with almost 60 other important cancer research advances—are described in ASCO's just-released report, Clinical Cancer Advances 2016: ASCO's...
Studies Confirm and Extend the Benefits of Ixazomib in Multiple Myeloma
Patients with multiple myeloma now have access to an all-oral regimen, with the recent approval of the oral proteasome inhibitor ixazomib (Ninlaro) in previously treated patients. New pairings for the drug in relapsed/refractory and newly diagnosed patients are being studied, with investigators...
New Appointments Within FDA’s Office of Hematology and Oncology Products
The U.S. Food and Drug Administration (FDA) recently announced the appointment of an Acting Deputy Office Director and an Associate Director of Clinical Science in its Office of Hematology and Oncology Products (OHOP). Acting Deputy Office Director Amy E. McKee, MD, was recently announced as the...
Pembrolizumab Label Updated With New Clinical Trial Information
Late in 2015, the U. S. Food and Drug Administration (FDA) expanded the label for pembrolizumab (Keytruda), a humanized antibody, to include the initial treatment of patients with unresectable or metastatic melanoma. Previously, pembrolizumab had received accelerated approval in patients with...
Two Contenders for Second-Line Treatment of Advanced Renal Cell Carcinoma
Options for second-line therapy of advanced/metastatic renal cell carcinoma are expanding. Updates from the CheckMate 025 and METEOR trials presented at the 2016 Genitourinary Cancers Symposium solidify the value of both nivolumab (Opdivo, an immune checkpoint inhibitor) and cabozantinib...
John Smyth, MD, on The Current State of Cancer Research and Treatment: The European Perspective
John Smyth, MD, of the University of Edinburgh, discusses oncology from an international point of view.
Winning the Battle at the Front Lines: Lenalidomide Plus Rituximab— A Promising Initial Treatment for Mantle Cell Lymphoma
Mantle cell lymphoma is a pernicious, incurable disease. Front-line therapies for this disease are not currently standardized; however, novel therapies for relapsed or refractory mantle cell lymphoma can ideally be translated into beneficial treatments for newly diagnosed patients, as clearly...
E-Cigarette Advertisements Reach Nearly 7 in 10 Middle and High School Students
About 7 in 10 middle and high school students—more than 18 million young people—see e-cigarette advertising in stores, online, in newspapers and magazines, or on television and in movies, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report. E-cigarette ads use...
The Evolving Treatment Landscape of ALK-Positive NSCLC
Since the initial discovery of ALK rearrangement in non–small cell lung cancer (NSCLC) in 2007,1 small molecule tyrosine kinase inhibitors of ALK have transformed the course of disease for those patients with ALK-rearranged (ie, ALK-positive) NSCLC. Crizotinib (Xalkori), a multitargeted tyrosine...
Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity
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 11, 2015, uridine triacetate (Vistogard) was approved...
Immunotherapy for Breast Cancer: Early Lackluster Study Results yet Promise Remains
Immunotherapy is at the forefront of exciting new approaches to cancer, with excellent and long-lasting responses in metastatic melanoma and non–small cell lung cancer (NSCLC) and several immunotherapy agents now approved for those malignancies by the U.S. Food and Drug Administration (FDA). The...
Venetoclax May Prove to Be Strong Weapon Against Poor-Prognosis Chronic Lymphocytic Leukemia
Venetoclax, the latest entry into the field of treatment of chronic lymphocytic leukemia (CLL), is a powerful investigational therapy that promises to fill an important niche: treatment of high-risk relapsed/refractory patients with deletions of 17p. Nearly 80% of patients with relapsed/refractory...
