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Showing 2401 - 2450FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have...
FDA Establishes Oncology Center of Excellence, Names Richard Pazdur, MD, Director
On January 19, 2017, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence and appointing Richard Pazdur, MD, as its Director. This will make oncology...
Immunotherapy 2.0 Named Advance of the Year in ASCO's Report
A growing number of patients with cancer are benefiting from research advances in immunotherapy, leading ASCO to name immunotherapy as the Society's Advance of the Year for a second year in a row. Released today, Clinical Cancer Advances 2017: ASCO's Annual Report on Progress Against Cancer...
What Have We Got to Lose?
Tuesday morning was the regular time for the departmental meeting—an opportunity to discuss cases, troubleshoot, debrief, and expedite the necessary allied health referrals. As usual, patient cases were being discussed in alphabetical order of the attending oncologist. We were already three...
Rucaparib in Previously Treated BRCA Mutation–Associated Ovarian Cancer
On December 19, 2016, rucaparib (Rubraca) was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) advanced ovarian cancer who have received two or more prior chemotherapy regimens.1,2 The U.S. Food and Drug Administration (FDA) ...
FDA Approves Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties
On January 9, the U.S. Food and Drug Administration (FDA) approved morphine sulfate extended-release tablets with abuse-deterrent properties (Arymo ER), a C-II drug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative...
Ibrutinib: A Potential Option for Chronic Graft-vs-Host Disease?
Currently, there is no U.S. Food and Drug Administration (FDA)-approved therapy for chronic graft-vs-host disease—a life-threatening consequence of stem cell or bone marrow transplant—that has not responded to corticosteroids, but this may be about to change. Ibrutinib (Imbruvica) achieved...
PARP Inhibitor Niraparib Yields ‘Unprecedented’ Results in Ovarian Cancer in Phase III Trial
The first phase III trial of an inhibitor of poly (ADP-ribose) polymerase (PARP) yielded unprecedented results in treating ovarian cancer. The trial was presented at the European Society for Medical Oncology (ESMO) in Copenhagen, Denmark, and electronically reported concurrently in The New England ...
Nivolumab in Squamous Cell Carcinoma of the Head and Neck in CheckMate 141: Game Not Over
Most patients with squamous cell carcinoma of the head and neck present with locally advanced disease. With combined-modality approaches, the chance of cure ranges from < 50% to up to 80%, depending on the site, stage, and other risk factors, such as human papillomavirus (HPV) status. When...
CAR T-Cell Therapy KTE-C19 Appears Successful in Aggressive B-Cell Lymphoma
Chimeric antigen receptor (CAR) T-cell therapy continues to have impressive showings in patients with aggressive hematologic malignancies and no other good treatment options. Interim results of the pivotal phase II ZUMA-1 trial, the first multicenter trial of the experimental CAR T-cell therapy...
Selected Abstracts From the 2016 San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer Symposium....
Oncology Drug Approvals in 2016
In 2016, the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) approved a number of new molecular entities, indications, and tests. The most notable were drug approvals in disease areas such as non–small cell lung cancer, myeloma, head and neck cancer, and...
FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma
The U.S. Food and Drug Administration (FDA) today approved ibrutinib (Imbruvica) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti–CD20-based therapy. Accelerated approval was granted for this indication based on...
FDA Officially Establishes the Oncology Center of Excellence, Names Richard Pazdur, MD, as Director
Today, the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: “Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Richard Pazdur, MD, as its Director. This will make...
Institute for Clinical Immuno-Oncology White Paper Highlights the Challenges, Progress, and Priorities in Immunotherapy
While momentum around immunotherapies for cancer continues to build, the high cost of these therapies places them at the center of debate about how best to define and measure value in cancer care. As these therapies are increasingly integrated into practice, all stakeholders—providers,...
Tucatinib Shows Clinical Benefit in Phase I Trial in HER2-Positive Breast Cancer
Phase I clinical trial data published by Moulder-Thompson et al in Clinical Cancer Research reported that the investigational anticancer agent tucatinib (formerly ONT-380) showed 'notable activity' in the treatment of HER2-positive breast cancer with . The 50 women treated had disease...
FDA Approves Morphine Sulfate Extended-Release Tablets Formulated With Abuse-Deterrent Properties
On January 9, the U.S. Food and Drug Administration (FDA) approved morphine sulfate extended-release tablets formulated with abuse-deterrent properties (Arymo ER) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative...
FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...
FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer
On January 4, the U.S. Food and Drug Administration (FDA) granted Priority Review status for the supplemental New Drug Application (sNDA) for regorafenib (Stivarga) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma in the United States. “Liver cancer is ...
Fulvestrant Plus Everolimus: New Second-Line Option for Postmenopausal Metastatic Breast Cancer
The addition of everolimus (Afinitor) to fulvestrant (Faslodex) doubled progression-free survival in postmenopausal women with hormone receptor–positive, HER2-negative metastatic breast cancer resistant to aromatase inhibitor therapy compared with fulvestrant plus placebo, according to the...
Oncology Organizations Applaud Passage of the 21st Century Cures Act
On Tuesday, December 13, President Obama signed into law the 21st Century Cures Act, landmark legislation designed to improve and accelerate the pace of biomedical research in the United States. ASCO Chief Executive Officer Clifford Hudis, MD, FACP, FASCO, attended the White House signing ceremony ...
FDA Permits Marketing of New Tissue Expander for Women Undergoing Breast Reconstruction Following Mastectomy
On December 21, the U.S. Food and Drug Administration (FDA) allowed marketing of a new tissue-expander system for soft-tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft-tissue deformities. A patient uses a dose...
Expert Point of View: Mikkael A. Sekeres, MD, MS
Mikkael A. Sekeres, MD, MS, Director of the Leukemia Program at the Cleveland Clinic Taussig Cancer Center in Ohio, commented on vadastuximab talirine in newly diagnosed acute myeloid leukemia (AML). He noted that the drug is similar to gemtuzumab ozogamicin, another antibody-drug conjugate that...
Weighing the Benefits and Risks of Medical Marijuana
Despite the fact that 28 states and the District of Columbia have enacted laws to permit the use of cannabis and cannabinoid-based drugs to treat medical conditions, including cancer and symptoms from its treatment, federal law prohibits physicians from prescribing marijuana to their patients,...
Accelerating Progress in the Treatment of Glioblastoma Multiforme
W.K. Alfred Yung, MD, has wanted a career in medicine since he was a high-school student and has spent nearly 4 decades fulfilling that dream, specifically in the research and treatment of one of the deadliest cancers, malignant brain tumor, especially glioblastoma multiforme, the most common...
FDA Approves Rucaparib and Companion Genetic Test in Advanced Deleterious BRCA-Mutated Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to rucaparib (Rubraca) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved...
WCLC 2016: Phase II LUME-Meso Trial on Oral Nintedanib in Mesothelioma Demonstrates Meaningful Clinical Benefit
The LUME-Meso phase II trial in patients with unresectable malignant pleural mesothelioma met its primary endpoint of progression-free survival. The data, presented at the 17th IASLC World Conference on Lung Cancer (WCLC) in Vienna (Abstract 4191 #OA22.02), showed nintedanib (Ofev) plus...
SABCS 2016: Scalp-Cooling Device Safe and Effective in Reducing Chemotherapy-Induced Alopecia in Women With Breast Cancer
Although adjuvant chemotherapy decreases the risk of breast cancer recurrence, it is associated with distressing side effects, including hair loss. A prospective randomized trial evaluating the safety and efficacy of the Orbis Paxman Hair Loss Prevention System (OPHLPS), a scalp-cooling device that ...
Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs
On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid...
Friends of Cancer Research Rethinks Traditional Clinical Trials
Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is ...
NCCN Launches Campaign to Eradicate Fatal Vincristine Errors
It is uniformly fatal and impossible to undo. When the chemotherapy drug vincristine is placed in a syringe and injected intrathecally—into the spinal fluid—the patient always dies. And despite safety guidelines and labels, deaths continue to occur. Now the National Comprehensive Cancer Network®...
ASCO’s TAPUR Study Now Has More Than 100 Participants Receiving Treatment Drugs and 25 New Clinical Trial Sites
More than 100 participants are now enrolled on study drug in ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study. The trial launched in March 2016 at 37 sites, and in November, it welcomed its newest participating clinical sites: Cancer Treatment Centers of America®,...
Reagan-Udall Foundation Announces Appointments of Ellen V. Sigal, PhD, and Richard L. Schilsky, MD
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the FDA, has elected Ellen V. Sigal, PhD, as its new Chairman, and Richard L. Schilsky, MD, as Vice ...
The FDA Ensures Quality and Safety of Generic Drugs in the United States
The U.S. Food and Drug Administration’s (FDA) generic drug program has substantially increased the availability of affordable, high-quality drugs in the United States. It is arguably the only really effective health-care cost–containment program. The more than 10,000 generic drugs currently...
Concerns About Safety of Generic Oncology Drugs Made in Developing Countries
In an article in The Lancet Oncology, Y. Tony Yang, ScD, of George Mason University, Charles L. Bennett, MD, PhD, MPP, of the University of South Carolina and colleagues from the United States, Europe, and Japan examined clinical, policy, safety, and regulatory considerations for generic oncology...
New Treatments for Lung Cancer in 2016
With drug approvals for immunotherapy in the first- and second-line settings, breakthroughs in targeting epidermal growth factor receptor (EGFR) mutations, and the rapid evolution of therapies that target anaplastic lymphoma kinase (ALK) rearrangements, 2016 has been an extraordinary year for lung...
FDA Approves Daratumumab in Combination Therapy for Patients With Multiple Myeloma Receiving at Least One Prior Treatment
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior...
ASH 2016: New Data Shed Light on Potential Advantages of Pacritinib for Patients With Myelofibrosis
Compared with standard therapy, pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, according to a late-breaking study presented by Mascarenhas et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition...
FDA Grants sBLA to Pembrolizumab for the Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for...
FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL
The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no ...
FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer
On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted...
FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from an...
FDA Approves Daratumumab in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Multiple Myeloma
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior...
Understanding Biosimilars and Their Impending Role in Oncology Care
Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S....
Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
Anti–PD-1 Contenders in Advanced Urothelial Cancer
Immunotherapy with anti–PD-1 (programmed cell death protein 1) and anti–PD-L1 (programmed cell death ligand 1) agents continues to advance in metastatic urothelial cancer, with positive showings in two clinical trials presented at the 2016 European Society for Medical Oncology (ESMO) Congress. The...
Clinical Strategies for Improving Endocrine Therapy in Metastatic Breast Cancer
Most women with hormone receptor–positive breast cancer receive endocrine therapy as part of their treatment, but “the reality is that patients who receive antihormone therapy in the metastatic disease setting ultimately develop disease progression, ” William J. Gradishar, MD, stated at the 18th...
Cautious Optimism About Olaratumab in Soft-Tissue Sarcoma
The current plethora of drugs in development for oncology is leading to the testing of novel agents in common as well as rare diseases. Targeted therapies have been a focus of great interest in soft-tissue sarcomas, with testing of a variety of oral tyrosine kinase inhibitors leading to the...
Pembrolizumab as First-Line Therapy in Metastatic NSCLC: Practice-Changing Implications of KEYNOTE-024 Trial
We are in the midst of a paradigm shift in lung cancer. In the past 2 years, the anti–programmed cell death protein 1 (anti–PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) were found to improve overall survival in the second-line setting compared with docetaxel for patients with...
ASCO’s TAPUR Study Has More Than 100 Participants Receiving Treatment Drugs and 25 New Clinical Trial Sites
More than 100 participants are now enrolled on study drug in ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study. The trial launched in March 2016 at 37 sites, and in November, it welcomed its newest participating clinical sites: Cancer Treatment Centers of America,...
