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Showing 2751 - 2800FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. The President’s order, issued last October 31, directed the FDA to take action to help further prevent and reduce...
Pre–Annual Meeting Seminar Series Kicks Off
This year, ASCO is cosponsoring a new series of intimate, discussion-based seminars to be held just before the start of the Annual Meeting in June. The three seminars, which start at 1:00 PM on Thursday, May 31, and continue through noon on Friday, June 1, the first day of the Annual Meeting, are: ...
ASCO Launches Community Research Forum to Tackle Top Research Conundrums
Just how many research-focused staff members is it optimal to have when conducting clinical trials in a community-practice setting? To properly gauge that, should the practice look closely at how many studies it’s working on? The complexity of those studies? The number of patients enrolled? Some...
Answer to Secondary Cancers with RAF Inhibitors May Be Concomitant MEK Inhibition
Keratoacanthomas and cutaneous squamous cell carcinomas are frequently observed in patients receiving the RAF inhibitor vemurafenib (Zelboraf) for treatment of BRAF-mutated melanoma. As discussed by Lacouture and colleagues in a recent Journal of Clinical Oncology article, these effects appear to...
Immune Changes Reported with Early Use of Sipuleucel-T in Neoadjuvant Setting for Prostate Cancer
Sipuleucel-T (Provenge) can generate a circulating immune response to treat men with metastatic castrate-resistant prostate cancer, as per its FDA-approved indication.1 A neoadjuvant trial was performed to investigate whether earlier use of sipuleucel-T can generate an immune response in the...
Searching for Quality in an Increasingly Complex Health-care Environment
With the Presidential election just around the corner, the health-care debate will undoubtedly heat up. The ASCO Post spoke with Sean R. Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy, and former Chief Medical Officer for the Centers for Medicare & Medicaid Services, ...
GU Symposium 2016: Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer
New analyses from a phase III clinical trial of patients with previously treated advanced kidney cancer demonstrated that patients of all risk levels experience more benefit from cabozantinib (Cometriq) than from the current standard of care, everolimus (Afinitor). The greater activity of...
ASCO’s Blueprint Sets Goals for Accelerating Cancer Progress
ASCO recently issued a report, Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research, which outlines the Society’s 10-year plan for improving cancer outcomes. Central to achieving that goal are three steps, including (1) therapy...
FDA Drug Approvals, January–April 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Vismodegib capsules (Erivedge) approved for the treatment of metastatic basal cell carcinoma or locally...
Liposomal Vincristine Receives Positive Vote from ODAC
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
FDA Approves New Silicone Gel–filled Breast Implant
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
FDA Commissioner Statement: Surgeon General’s Report on Youth Smoking
The recent report on “Preventing Tobacco Use Among Youth and Young Adults” by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to...
ODAC Offers Recommendations on Two Sarcoma Drugs
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently recommended approval of one drug for sarcoma but rejected another. The panel voted 11 to 2 that clinical studies support a favorable benefit-risk assessment for use of pazopanib (Votrient) in treating patients with advanced soft-tissue...
Update on Novel Anticoagulants: Dabigatran Etexilate
Efficacy and safety of traditional anticoagulants (eg, vitamin K antagonists) are well recognized, given their long-standing use in clinical practice. However, the novel anticoagulants have several potential advantages over the vitamin K antagonists. Even so, in light of their recent introduction...
Treating Acute Promyelocytic Leukemia without Chemotherapy
Throughout the course of medical history, we have witnessed innovations that have initially been met with skepticism but have later revolutionized our management of patients with specific disorders. The recent history of oncology drug development is full of instances where a drug that was...
ASCO Advocates for Solutions to Oncology Drug Shortage Crisis
ASCO continues to call for three specific actions by Congress to help avert shortages of essential treatments for children and adults living with cancer. ASCO President Michael P. Link, MD, outlined the priorities in February at an FDA news briefing on the recent methotrexate and liposomal...
Cancer Informatics: A Future Necessity, but Challenges Abound
The National Cancer Policy Forum of the Institute of Medicine (IOM) recently convened a workshop on cancer informatics to examine and discuss needs and challenges facing biomedical researchers, which will in turn affect the way oncology is practiced in the future. “This is a time of huge scientific ...
An Expert Shares Insight into the Future of Lung Cancer Treatment
Despite growing national focus on early detection, prevention, and new molecular-based treatments, lung cancer persistently remains the number 1 cause of cancer death for men and women in the United States. The ASCO Post spoke to lung cancer specialist Paul A. Bunn, Jr, MD, Executive Director,...
Surgeon General Releases New Report on Youth Smoking
The fight against tobacco use among young people was accelerated recently by Surgeon General Regina M. Benjamin, MD, MBA, with the release of the Surgeon General’s Report, Preventing Tobacco Use Among Youth and Young Adults. This report details the scope, health consequences, and influences that...
Institute of Medicine Report on Omics-based Testing Bolsters ASCO’s Blueprint for Transforming Cancer Research
A recent report by the Institute of Medicine (IOM) addresses elements that ASCO has stated are necessary for transforming the therapeutic development and clinical trial processes. In March, the IOM released the report “Evolution of Translational Omics: Lessons Learned and the Path Forward,” which...
FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344
Marshall Edwards, Inc, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced that it has received approval from the FDA of its Investigational New Drug (IND) application for ME-344, the Company’s lead mitochondrial inhibitor. The...
Clinical Findings and Consequences of Distributing Counterfeit Drugs for Hematology and Oncology
As introduced in our report on page 1 of this issue, counterfeit pharmaceuticals are an increasingly important safety concern, and three of the most prominent drug-counterfeiting episodes in recent years have involved hematology/oncology products. Counterfeit Erythropoietin Helen B., a 61-year-old...
Defining Meaningful Benefit: The Debate Continues in Bevacizumab’s Wake
The events surrounding the labeling of bevacizumab (Avastin) have been well covered since last November when the FDA withdrew the drug’s accelerated approval as a treatment for metastatic breast cancer. However, the controversy initiated a debate over the value of endpoints in clinical trials in...
Caveat Oncologist: Counterfeit Pharmaceuticals
In 2002, Tim F., a 17-year-old liver transplant patient, received 40,000 units of erythropoietin weekly, beginning immediately after his transplantation procedure.1 His family had purchased the product from the local CVS Pharmacy, upon his discharge from a Manhattan hospital. After each injection,...
Expert Point of View: Novel Multikinase Inhibitor Improves Survival in Metastatic Colorectal Cancer
The results of the CORRECT trial created some degree of “buzz” at the 2012 Gastrointestinal Cancers Symposium, with experts predicting that regorafenib will become FDA-approved and have strong clinical utility. While numerically, the benefit appeared small, “There is a real difference with this...
SIDEBAR: Drug Development in the Era of Personalized Medicine
Advances in understanding cancer on a molecular level and the identification of subgroups of cancer patients with rare diseases are expected to have an effect on drug development and supply. “The vision of what cancer care will be like in the future is this very precise personalized care, where...
Update on Oncology Drug Shortage: Better for Now, But Permanent Solutions Must Address Underlying Issues
Over the past few years, drug shortages in the United States have been on the rise, involving hundreds of agents, many of which are lifesaving medications for patients with cancer. In recent months, the FDA has taken steps to alleviate some of the most critical oncology drug shortages. “We should...
ASCO President Michael P. Link, MD, Makes Statement on Passage of FDA Safety and Innovation Act
ASCO President Michael P. Link, MD, recently issued the following statement in response to the Senate Health, Education, Labor and Pensions Committee’s Passage of the FDA’s Safety and Innovation Act: “ASCO commends the Senate Health, Education, Labor and Pensions Committee for taking steps to...
FDA Strengthens Monitoring of Postapproval Drug Safety
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to a new report released by the agency’s Center for Drug Evaluation and Research (CDER). The report, Advances in...
FDA Reminds Public about Potential for Life-threatening Harm from Accidental Exposure to Fentanyl Patches
The FDA has issued a statement reminding patients, caregivers, and health-care professionals of the importance of appropriate storage, use, application, and disposal of fentanyl transdermal systems (including Duragesic and generic products) to prevent potential life-threatening harm from accidental ...
Automated HER2 Immunohistochemical System Approved
Leica Biosystems, a division of Leica Microsystems, announced that it has received premarket approval from the FDA for its Bond Oracle HER2 IHC System, a semi-quantitative immunohistochemical assay to determine human epidermal growth factor receptor 2 oncoprotein status in formalin-fixed,...
FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported Products
FDA Commissioner Margaret A. Hamburg, MD, recently released the agency’s Global Engagement Report, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report describes the steps the agency is taking to ensure that imported...
JAMA Highlights New Comparative Effectiveness Studies
A recent press briefing moderated by Phil B. Fontanarosa, MD, MBA, Executive Editor, JAMA, presented new findings on comparative effectiveness research, and two of the studies discussed focused on cancer. Dr. Fontanarosa started by defining comparative effectiveness research, which gained...
FDA Approves Pazopanib for Advanced Soft-tissue Sarcoma
The FDA has approved pazopanib (Votrient) to treat patients with advanced soft-tissue sarcoma who have previously received chemotherapy. Pazopanib is an oral agent that works by interfering with angiogenesis. Soft-tissue sarcoma occurs in about 10,000 cases annually in the United States. More than ...
Advances in Prostate Cancer Accompanied by Ongoing Debates
Scientific advances have markedly improved prostate cancer survival, but this clinical success story is not without its share of controversy. From screening through treatment, a growing array of options offer an admixture of promise and confusion for clinicians and patients. Moreover, today’s...
New Breast Biopsy System with Vacuum Technology Approved
Devicor Medical Products, Inc, announced that it has received 510(k) clearance from the FDA for the Mammotome elite Biopsy System, a tetherless single-insertion, multiple-sample, vacuum-assisted biopsy device featuring proprietary vacuum technology. Devicor also announced the commercial launch of...
New Drug Application Submitted for Regorafenib for the Treatment of Metastatic Colorectal Cancer
Bayer HealthCare announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the oral multikinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer. The submission is based on the results of the pivotal, global phase III CORRECT...
Denosumab Delays Time to First Bone Metastasis in Men with Castration-resistant Prostate Cancer
Denosumab (Xgeva) significantly delayed time to first bone metastases among men with nonmetastatic castration-resistant prostate cancer enrolled in a phase III randomized, placebo-controlled trial. The time to first bone metastasis was 33.2 months among the 716 patients randomly assigned to receive ...
FDA-led Research Team Discovers Autoimmune Mechanism for Drug-induced Adverse Reactions
A team of researchers led by the FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. In an article available online in the journal AIDS, the team reported that in certain at-risk patients, the anti-HIV drug abacavir (Ziagen) causes the immune...
Aflibercept Granted Priority Review for Metastatic Colorectal Cancer
Sanofi and Regeneron Pharmaceuticals, Inc, recently announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent aflibercept (Zaltrap) concentrate for solution for infusion in combination with irinotecan/fluoropyrimidine–based...
FDA Approves Drugs Faster than Canadian and European Counterparts
According to a study published online in The New England Journal of Medicine (May 16, 2012), the FDA approved more new drugs in less time—about 15% faster—than the European Medicines Agency and Health Canada. The analysis compared drug review performance for the three agencies from 2001 to 2010....
Drug Safety Communication Issued Regarding Lenalidomide and Risk of New Malignancies
The FDA recently released a safety announcement about an increased risk of second primary malignancies in patients with newly diagnosed multiple myeloma who received treatment with lenalidomide (Revlimid). Clinical trials conducted after lenalidomide was approved showed that newly diagnosed...
Multiple Myeloma Research Foundation Initiatives Are Leading to More Effective Targeted Treatment
In 1996, at just 37, the last thing Kathy Giusti expected to hear was that she had the fatal blood cancer multiple myeloma. An executive at Searle Pharmaceuticals and the mother of an 18-month-old daughter, Giusti was told she probably had 3 years to live. At the time, treatments for the disease...
ASCO Participates in Two FDA Meetings on Improving Clinical Trials
ASCO recently took part in two public meetings at the U.S. Food and Drug Administration (FDA) that had the broad goal of improving clinical trials and, ultimately, treatment for cancer patients. Then ASCO President Michael P. Link, MD, served as a panelist on a workshop sponsored by FDA and ASCO,...
Markers in Cancer 2012, to be Held October 11–13, Will Seek to Move the Field of Biomarkers to the Next Phase
There are hundreds and hundreds of papers published on biomarkers in cancer each year, but very few make it over the hurdles necessary to be used in actual patient care, said James L. Abbruzzese, MD, Chair of the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson ...
Antipsychotic Effectively Controls Chemotherapy-induced Breakthrough Nausea and Vomiting
Olanzapine (Zyprexa), an FDA-approved antipsychotic, effectively controlled chemotherapy-induced nausea and vomiting (CINV) in patients who failed to respond to guideline-recommended antiemetic therapy in a phase III trial presented at the ASCO Annual Meeting.1 “This is the first randomized trial...
Encouraging Results with Neoadjuvant Therapy for High-risk Prostate Cancer
Use of the CYP17 inhibitor abiraterone acetate (Zytiga) in combination with leuprolide and prednisone prior to radical prostatectomy achieved pathologic complete response or near complete response in one-third of men with high-risk, localized prostate cancer. Abiraterone is FDA-approved for...
After 3 Decades at MD Anderson, Leukemia Researcher Shows No Sign of Slowing Down
Hagop M. Kantarjian, MD, Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, was born in Lebanon. The only member of his family to have pursued a career in medicine, he received his medical degree from the American University of Beirut (AUB), which was founded...
Reflections on the Evolution of Clinical Cancer Research and Turning Points in a Distinguished Career
Since May 1, 2005, Karen H. Antman, MD, has served as Dean of Boston University School of Medicine and Provost of the Boston University Medical Campus, located in the historic South End of Boston. Her road to this esteemed institution was paved with prominent positions, such as former ASCO...
Supplemental New Drug Application Submitted for Abiraterone
Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the FDA to extend the use of abiraterone acetate (Zytiga) administered with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or...
