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Showing 2551 - 2600New FDA Rule Prohibits Sale of E-Cigarettes to Anyone Under Age 18 and Requires Warning Labels
A new rule extending U.S. Food and Drug Administration (FDA) oversight to all tobacco products, including electronic cigarettes (e-cigarettes), and banning the sale of these products to anyone under the age of 181 was hailed as a major advanced by many leaders of medical and health organizations....
Cabozantinib in Advanced Renal Cell 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. On April 25, 2016, a tablet formulation of cabozantinib...
Breast Cancer Research Foundation: Revitalizing Academic Research in Breast Cancer Through Drug Research Collaborative
When Evelyn H. Lauder was diagnosed with breast cancer in 1989, she became a vocal spokesperson for women’s health, and in 1993, along with Larry Norton, MD, now Deputy Physician-in-Chief for Breast Cancer Programs and Medical Director of the Evelyn H. Lauder Breast Center at Memorial Sloan...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2016 Guidelines
In 1996, the National Comprehensive Cancer Network (NCCN®) published its first set of Clinical Practice Guidelines in Oncology® (NCCN Guidelines®), covering eight tumor types. The NCCN Guidelines® are now published for more than 60 tumor types and topics. Some of the key updates for 2016 were...
FDA Approves Nivolumab for Heavily Pretreated Classical Hodgkin Lymphoma
On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the programmed cell death protein 1 (PD‑1) inhibitor, nivolumab (Opdivo), for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem...
How Immunotherapy Is Revolutionizing Cancer Care
More than 100 years after William B. Coley, MD, used bacterial toxins to goad the immune system into recognizing cancer cells as foreign to the body and mount an immune response to go after and kill them, the recognition of immunotherapy as a powerful anticancer therapy is finally being...
Maximizing Cancer Cure: How Do We Get There?
Is cancer really “curable,” and if so, how? For a “Cancer Dialogue” held during the 2016 American Association of Cancer Research (AACR) Annual Meeting, half a dozen stellar participants from the research, industry, regulatory, and advocacy communities convened to debate the topic. The ASCO Post was ...
The Arrival of Generic Imatinib Into the U.S. Market: An Educational Event
Imatinib mesylate (Gleevec), a Bcr-Abl tyrosine kinase inhibitor, is approved therapy for chronic myeloid leukemia (CML) in the United States. Imatinib is a miraculous drug that results in a normal functional lifespan in most patients with CML who can afford and comply with the treatment and who ...
ASCO 2016: Autologous Stem Cell Transplant Remains Relevant in Multiple Myeloma, Even in Era of Novel Agents
Early findings from a phase III clinical trial (EMN02/HO95 MM) showed that patients with multiple myeloma who received an autologous stem cell transplant survived longer without disease progression than those who received only chemotherapy using novel agents. This is the largest study reported to...
FDA Approves Atezolizumab for Advanced Urothelial Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitor to be...
FDA Grants Accelerated Approval to Nivolumab in Classical Hodgkin Lymphoma
On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and...
Addition of Ixazomib to Lenalidomide/Dexamethasone Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma
Moreau et al found that adding the oral proteasome inhibitor ixazomib (Ninlaro) to lenalidomide (Revlimid) and dexamethasone significantly prolonged progression-free survival among patients with relapsed, refractory, or relapsed and refractory multiple myeloma. They reported the findings from the...
FDA Approves Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma
On May 13, 2016, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima), in combination with everolimus (Afinitor) for the treatment of advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib was first approved in 2015 for the treatment...
Combining Two FDA-Approved Diagnostic Tests Increased Detection of High-Grade Cervicovaginal Lesions
Cytopathology researchers at Houston Methodist Hospital recently found that combining two diagnostic tests—the Papanicolau (Pap) and high-risk human papillomavirus (hrHPV)—dramatically decreased the chance of missing tumors and high-grade lesions by sevenfold. Zhou et al published...
FDA Grants Selumetinib Orphan Drug Designation for Adjuvant Treatment of Differentiated Thyroid Cancer
AstraZeneca announced on May 12 that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer. Differentiated...
FDA Launches First Campaign Focused on Dangers of Smokeless Tobacco Among Rural Teens
The U.S. Food and Drug Administration (FDA) has announced it is expanding its award-winning “The Real Cost” campaign to educate rural white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco...
Breakthrough Therapy Efforts Result in Unprecedented Success
Friends of Cancer Research (Friends) and the U.S. Food and Drug Administration (FDA) have been working together for many years on an idea known as breakthrough therapy, and it has produced results beyond anyone’s hopes. Said Ellen Sigal, PhD, Friends Chair and Founder, “When we were first talking...
Defibrotide Sodium for Hepatic Veno-occlusive Disease After HSCT
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 March 30, 2016, defibrotide sodium (Defitelio) was approved for...
Breaking Down Dogma With the Outgoing President of SGO
At the 2016 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, The ASCO Post sat down with the SGO’s outgoing President, Robert L. Coleman, MD, and discussed the revolutionary potential of blood biomarkers, why enhanced recovery after surgery protocols is a significant...
FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a dual tyrosine kinase inhibitor of MET and VEGFR2. The capsule...
FDA Grants Priority Review for BLA for Olaratumab in Advanced Soft-Tissue Sarcoma
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the biologics license application (BLA) for olaratumab, a platelet-derived growth factor receptor alpha (PDGFRα) antagonist, in combination with doxorubicin, for the...
FDA Grants sBLA for Blinatumomab in Pediatric Patients With Ph–Negative Relapsed/Refractory B-Cell Precursor ALL
Amgen announced on May 3 that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia...
FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a dual tyrosine kinase inhibitor of MET and VEGFR2. The...
FDA Grants Breakthrough Designation to Nivolumab in Squamous Cell Carcinoma of the Head and Neck
On April 25, 2016, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to the anti–programmed death 1 antibody nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck that previously received...
Friends of Cancer Research Encourages FDA to Modernize and Consolidate
“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes...
Drug 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...
