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Showing 2801 - 2850SIDEBAR: 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...
FDA Approves Pertuzumab for HER2-positive Metastatic Breast Cancer
The FDA has approved pertuzumab (Perjeta), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, pertuzumab is combined with...
Too Soon to Know How Circulating Tumor Cells Might Be Used to Guide Treatment of Breast Cancer
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. “A simple blood test.” These were...
Novel Agent Carfilzomib Receives Positive Vote from Oncologic Drugs Advisory Committee for Use in Multiple Myeloma
Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11–0 (with 1 abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome...
SIDEBAR: Expect Questions from Your Patients
Promising results announced at the recent ASCO Annual Meeting from studies with BRAF and MEK inhibitors have made headlines, but only one of these agents—the BRAF inhibitor vemurafenib (Zelboraf)—has been approved by the FDA. The others are still investigational. Patients interested in gaining...
MEK Inhibitor Reduces Progression of BRAF-mutated Melanoma and Might also Benefit Others
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. The MEK inhibitor trametinib...
Cabozantinib Prolongs Progression-free Survival in Advanced Medullary Thyroid Cancer
Cabozantinib prolonged progression-free survival in patients with unresectable, locally advanced, or metastatic medullary thyroid cancer with documented disease progression in the phase III EXAM trial. Based on these results, Exelixis submitted a New Drug Application to the FDA in May 2012. The...
NK Cell Signature Associated with Favorable Prognosis in Breast Cancer
Tumor cell recognition by natural killer (NK) cells is mediated by the interaction of activating and inhibitory NK cell receptors with ligands expressed on the tumor cells. NK cells also express adhesion molecules that facilitate formation of the immune synapse with tumor targets. Maria Libera...
Blood Test to Improve Prostate Cancer Detection
Beckman Coulter, Inc, recently announced Premarket Approval from the FDA for the Prostate Health Index, a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range and has...
System for Breast Cancer Surgeries Gets Positive Vote
Dune Medical Devices announced that an FDA Advisory Panel voted 10 to 1 in favor of Dune’s MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment. Dune submitted a Premarket Application (PMA) in April 2011 based on ...
Regorafenib in Metastatic Colorectal Cancer
Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose...
Proton Therapy System Granted 510(k) Clearance
Mevion Medical Systems, Inc, announced that it has received FDA 510(k) clearance for its Mevion S250 Proton Therapy System. According to Mevion, the new system delivers precise, noninvasive treatment comparable to that available with larger, more complex proton therapy systems but with higher...
FDA Approves Cetuximab plus FOLFIRI/Therascreen in Colorectal Cancer
The FDA has granted approval to cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation–negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. ...
After a Decade of Decline in Smoking Rates, Progress Has Stalled
Approximately 20% of all Americans smoke, and 443,000 of them will die each year as a result. Tobacco use is the leading cause of preventable death in the United States and the greatest behavioral determinant of morbidity and mortality (6%–10% of U.S. health-care costs). Nearly 30% of all cancer...
PACE Trial Update: Ponatinib Produces High Response Rates in CML
The third-generation tyrosine kinase inhibitor ponatinib showed robust efficacy in the 10-month follow-up of the phase II PACE trial (Ponatinib Ph+ALL and CML Evaluation), which is evaluating ponatinib in treatment-refractory chronic myeloid leukemia (CML)1 At the 2012 ASCO Annual Meeting, Jorge E. ...
First-line Afatinib Superior to Standard Chemotherapy in Advanced EGFR-mutated Non–Small Cell Lung Cancer
First-line therapy with the investigational oral agent afatinib improved progression-free survival compared with standard chemotherapy (pemetrexed (Alimta)/cisplatin) in patients with advanced non–small cell lung cancer (NSCLC) harboring an EGFR mutation. Afatinib improved progression-free survival ...
Expert Point of View: Landscape for Treatment of Metastatic Melanoma Is Expanding
At an Annual Meeting press conference, ASCO spokesperson Sylvia Adams, MD, said, “BREAK-3 confirms that BRAF targeting is effective in metastatic melanoma. The tumor shrinkage seen with dabrafenib is similar to results observed for the FDA-approved drug vemurafenib, with fewer side effects. We will ...
Landscape for Treatment of Metastatic Melanoma Is Expanding
Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...
SIDEBAR: Expect Questions from Your Patients
For now, genomic sequencing seems to have a greater presence in the news than in the clinic. What can physicians tell their patients who ask about genetic testing to identify mutations driving cancer growth? “The real answer is that when you get down to it, genomics is like any other test,”...
Genomics vs Site of Cancer Origin as Basis for Treatment of Cancer Is ‘False Dichotomy’
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Despite recent news reports...
Pertuzumab: New Drug for HER2-positive Metastatic 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 In June 2012, pertuzumab (Perjeta) was approved for use...
Symposium Focuses on Policy Issues in Personalized Cancer Care
“What is the biggest barrier to progress in personalized medicine?” asked moderator Anna Barker, PhD, leading a panel discussion at a recent meeting convened by the Washington-based advocacy group, the Personalized Medicine Coalition, with the American Association for Cancer Research and Feinstein...
Information Service Provides Innovative Resource for Patients and Providers
Jennifer Levin Carter, MD, MPH is Founder and President of N-of-One. A board-certified internist and entrepreneur, she has more than 20 years of experience evaluating existing and emerging markets, new medical technologies, and early-stage companies in the health-care field. Formerly, Dr. Carter...
Supportive Care Experts Explore 30 Years of Progress in the Field
Thirty years ago, when the first supportive care meeting as a forerunner of the Multinational Association of Supportive Care in Cancer (MASCC) Symposium was held in New York, supportive care was largely ignored, with little discussion at major cancer meetings, which focused primarily on...
Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...
Everolimus Approved for Advanced Breast Cancer
The FDA has approved everolimus tablets (Afinitor) for use in combination with exemestane to treat postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer after failure of treatment with letrozole or anastrozole. The approval was based on a randomized,...
