Search Results
Your search for ,Fda matches 3728 pages
Showing 3001 - 3050Oncologists Speak Out Against the High Cost of Cancer Drugs
That the United States spends twice as much on health care than other industrialized countries—about $2.8 trillion in 2012—without reaping appreciably better outcomes1 is not news. The topic has been dissected on the front pages of leading newspapers for years and was the subject of the entire...
Role of Erlotinib in EGFR Wild-Type Lung Cancer
I welcomed Matthew Stenger’s Journal Spotlight on the TAILOR trial in the August 15 issue of The ASCO Post (“Docetaxel Superior to Erlotinib in Second-Line Treatment of Advanced Non–Small Cell Lung Cancer With Wild-Type EGFR”). The trial was recently published online in Lancet Oncology,1 and...
Dr. Julie Vose Finds the Best of Both Worlds—Patient Care and Cutting-Edge Research—in Academic Medicine
Julie M. Vose, MD, MBA, is the Neumann M. and Mildred E. Harris Professor and Chief of the Division of Hematology/Oncology at the University of Nebraska Medical Center. She grew up in Mitchell, South Dakota, a small town nestled on the banks of the James River. Mitchell is home to the Corn Palace,...
Enhanced Treatment, Surveillance Needed for Patients With BRAF-Mutant Melanoma to Prevent Secondary Cancers
Researchers at Moffitt Cancer Center suggest secondary cancers seen in melanoma patients who are being treated for a BRAF gene mutation may require new strategies, such as enhanced surveillance and combining BRAF inhibitor therapy with other inhibitors, especially as they become more widely used....
FDA Approves First Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The U.S. Food and Drug Administration (FDA) approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as ...
Merkel Cell Carcinoma: Hints of Immune Mediation May Enhance Treatment Options
Merkel cell carcinoma is a rare but aggressive skin cancer with poor outcomes and suboptimal therapeutic options. With a 46% mortality rate, it is three times more lethal than melanoma, and its reported incidence is rising. “Merkel cell carcinoma is a nasty cancer and we have zero FDA-approved...
Access to and Appropriate Use of Oncology Drugs Called Into Question by ASCO Studies
Studies presented at this year’s ASCO Annual Meeting suggest that despite the wealth of amazing oncolytics on the market, drug shortages persist, drug substitutions are common, off-label use of drugs occurs frequently, and patients find their costs burdensome. Drug Shortage Persists The shortage of ...
Addressing the Key Clinical Questions in Advanced Melanoma
At the 3rd Annual World Cutaneous Malignancies Congress, in La Jolla, California, Steven J. O’Day, MD, Director of Clinical Research at the Beverly Hills Cancer Center and Adjunct Member of the John Wayne Cancer Institute, Los Angeles, addressed what he labeled the “key clinical questions” about...
FDA on CLL Drug Approval and Expanded Access
The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...
Clinical Trials, Crossover, and Clinical Equipoise: An Advocate's Perspective
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
Clinical Trials, Crossover, and Clinical Equipoise: A Patient's Perspective
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
The Trials and Tribulations of a Revolutionary Cancer Drug
A modest brass plaque above a booth in the Eagle Pub in Cambridge, notes, “On this spot, on February 28, 1953, Francis Crick and James Watson declared the discovery of DNA with these words: ‘We have discoverewd the secret of life.’” Announcing a major scientific advance over a pint of ale is a far...
Sorafenib Granted Priority Review for Differentiated Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals recently announced that the FDA has granted priority review designation to the supplemental new drug application of sorafenib (Nexavar) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer....
FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma
Ceptaris Therapeutics, Inc, recently announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug mechlorethamine gel (Valchlor) for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have ...
Prescribing of Off-Label Chemotherapy Is Common, and Most Off-Label Drug Use Meets NCCN Compendium Criteria
Off-label prescribing of drugs remains common in oncology, but about two-thirds of off-label prescribing is consistent with the National Comprehensive Care Network (NCCN) compendium, according to a study1 reviewed at the Best of ASCO® ’13 meeting in Chicago by Monika K. Krzyzanowska, MD, MPH,...
Pomalidomide In Patients With Disease Progression Who Are Refractory to Bortezomib and Lenalidomide
The second-generation immunomodulatory drug pomalidomide (Pomalyst) “has shown impressive results in patients with multiple myeloma who are refractory to lenalidomide [Revlimid] and bortezomib [Velcade],” according to a review of clinical data leading to the drug’s approval by the FDA. In February, ...
SIDEBAR: Expect Questions About E-Cigarettes
E-cigarettes are in the news, in advertising, and in stores, and because their public use is still largely unregulated, they may be in your face. Being prepared to answer questions about their use may help patients make wise decisions. What are e-cigarettes? Electronic cigarettes or e-cigarettes, ...
What You Need to Know About E-Cigarettes
“I’ve seen a lot of puzzled people,” Alexander V. Prokhorov, MD, PhD, said, referring to people who see others using electronic or e-cigarettes. That puzzlement can go beyond wondering why people are smoking in public places and whether they are breaking the law, or just being annoying, to...
Straight Talk: The Future of Medical and Health Research
Nearly 200 scientists and stakeholders in the research community attended Research!America’s National Health Research Forum on September 12, at the Newseum’s Knight Conference Center in Washington, DC. Research!America’s President and CEO, Mary Woolley, opened the program. “The theme for this...
Radium-223 and Beyond in Metastatic Castration-Resistant Prostate Cancer
Metastasis to bone is the hallmark of prostate cancer and a major source of disease-related morbidity and mortality. In addition to prostate cancer cells, other major players in the vicious interactive cycle of prostate cancer bone metastasis are osteoblasts, osteoclasts, and mineralized bone...
FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer
On September 30, 2013, the FDA granted accelerated approval to pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel for patients with early-stage breast cancer in the neoadjuvant setting. Pertuzumab is the first FDA-approved drug for the neoadjuvant treatment of breast...
ASCO Survey: Drug Shortages Still a Problem Despite Slight Improvement
As part of its continued effort to monitor and assess the impact of oncology drug shortages, ASCO will be conducting the third round of its biannual survey of members. The results of the first two surveys indicated that serious problems persist in the accessibility of life-extending oncology drugs, ...
FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer
Syndax Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor (ER)-positive breast cancer when added to exemestane in postmenopausal women whose disease ...
FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer. “Patients with pancreatic cancer are often diagnosed after the...
FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The U.S. Food and Drug Administration (FDA) has approved the first generic version of capecitabine (Xeloda), an oral chemotherapy agent used in the treatment of metastatic colorectal cancer and breast cancers. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150...
Pathologic Complete Response as a Test Bed for Novel Therapies: Proceed—With Caution!
Pathologic complete response as assessed surgically after neoadjuvant treatment is being touted by some researchers as a stand-alone endpoint justifying early drug approval for breast cancer. They argue that it provides a more efficient means of testing the value of agents that might be useful in...
Nab-Paclitaxel in Metastatic Pancreas 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. Indication On September 6, paclitaxel protein-bound particles...
Cabozantinib in Medullary Thyroid Cancer: A Landscape-Shaping New Treatment
Medullary thyroid cancer is derived from parafollicular C cells in the thyroid gland. The disease is sporadic in about 75% of cases and hereditary in the remaining 25%.1 Oncogenic mutations in the gene for tyrosine kinase receptor rearranged during transfection (RET) are driver genetic alterations...
AACR Cancer Progress Report 2013 Highlights Critical Importance of Biomedical Research
On September 17, the American Association for Cancer Research (AACR) presented highlights of its 2013 Cancer Progress Report1 at the National Press Club in Washington, DC. AACR Chief Executive Officer Margaret Foti, PhD, MD (hc), opened the program with a double-edged message, first citing the...
'Master Protocol' Could Revolutionalize Trials in Lung Cancer, and Eventually Other Cancers
Cancer advocates and clinical trialists, for some time, have been proposing a radical change to the laborious drug development process—that industry, academia, funding sources, and other stakeholders actually pool their brain power and financial means and work together, not separately, to develop...
SIDEBAR: 2013 New Drug/Indication Approvals*
1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound)...
A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine
Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and postmarket...
FDA Grants Volasertib Breakthrough Therapy Designation in AML
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
ASCO Submits Comments on Numerous Federal Initiatives
ASCO helps shape the regulatory framework in which oncologists practice by reviewing and commenting on a wide range of rules, guidelines, and system changes issued by federal agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and...
Options for Management of Bone Health in Patients With Multiple Myeloma
Bone health is critical in patients with multiple myeloma, since up to 85% will suffer bone damage. Options for management include two FDA-approved bisphosphonates—pamidronate and zoledronic acid—and possibly the RANK-L inhibitor denosumab (Xgeva, investigational use). Importance of Supportive ...
New Strategies for Relapsed/Refractory Multiple Myeloma Explored
Although upfront therapy can achieve remission in multiple myeloma, most patients will ultimately relapse. Newer targeted therapies and genomic analysis are moving the management of relapsed/refractory multiple myeloma forward, according to Kenneth C. Anderson, MD, Director, Jerome Lipper Multiple...
Program Co-Directors Highlight Abstracts of Interest for the Upcoming 2013 San Antonio Breast Cancer Symposium
The Co-Directors of the 2013 CTRC-AACR San Antonio Breast Cancer Symposium, which will be held December 10–14, 2013, have highlighted what they consider to be the most important abstracts to be presented at the Symposium. In a telebriefing in advance of the December meeting, C. Kent Osborne, MD,...
Optimizing Anti-HER2 Treatment for Metastatic Breast Cancer in 2013
The good news about HER2-positive breast cancer is that recurrent disease is plummeting, owing to the impact of adjuvant trastuzumab [Herceptin]. Hopefully, first-line metastatic treatment is becoming a thing of the past,” said Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston....
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
Omega-3
Common Name: Polyunsaturated fatty acids (PUFAs) Brand Names: Omegaven, Max-EPA The use of dietary supplements by patients with cancer has increased significantly over the past 2 decades despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about...
SIDEBAR: Five Proposals for the FDA
At a forum convened by Friends of Cancer Research in September 2013, a panel of experts presented five proposals outlining how sponsors and FDA may be able to improve and expedite the process for the codevelopment and review of a companion diagnostic designed for use with a drug that has received...
FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients...
Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast 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. Indication On September 30, 2013, pertuzumab injection (Perjeta)...
FDA Announces Strategic Plan to Prevent Drug Shortages
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the...
Neoadjuvant Treatment of Early Breast Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
SIDEBAR: Brian J. Druker, MD, Discusses Ponatinib
In an interview with The ASCO Post following FDA’s recommendation that sales of ponatinib (Iclusig) be suspended, (see here) Brian J. Druker, MD, Director of Oregon Health & Science University Knight Cancer Institute and JELD-WEN Chair of Leukemia Research, had concerns about obtaining the drug ...
Investigational ALK Inhibitor Shows Promise in Patients With Crizotinib-Refractory, ALK-Positive NSCLC
Patients with non–small cell lung cancer (NSCLC) whose tumors have the ALK gene rearrangement usually respond to the drug crizotinib (Xalkori), with a median duration of response of approximately 10 months. In a study reported by Shirish Gadgeel, MD, of Karmanos Cancer Institute in Detroit, and...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth...
