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Showing 2951 - 3000Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System
Royal Philips Electronics recently announced that it has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography system that has the capability to enable future single-shot spectral imaging applications. High Breast Density High breast density is a known ...
FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Tilmanocept is an imaging drug that...
New Findings in Prostate and Kidney Cancers Clarify the Roles of Abiraterone, Finasteride, Bevacizumab, and Surveillance
Attendees at the 2013 Genitourinary Cancers Symposium in Orlando, Florida, were brought up to date with the latest news on cancers of the prostate, testes, bladder, and kidney. Below are selected highlights from the meeting describing findings of noteworthy abstracts to extend our regular news...
Errata
In the March 1 issue of The ASCO Post, the article on page 2, “Outcomes Comparable for Panitumumab and Bevacizumab in Metastatic Colorectal Cancer,” contained an inaccuracy about the FDA-approved indications of bevacizumab (Avastin) in colorectal cancer. Specifically, the article noted that...
Homoharringtonine/Omacetaxine: The Little Drug that Could
First, a clarification: Homoharringtonine is a natural plant alkaloid derived from Cephalotaxus fortunei; from the 1970s until the present, it was the subject of intensive research efforts by Chinese investigators to clarify its role as an antileukemic agent.1-3 Omacetaxine mepesuccinate (Synribo)...
American Association for Cancer Research Honors Award Recipients at Annual Meeting
The American Association for Cancer Research (AACR) named the following as recipients of awards at the recent Annual Meeting. Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Cancer Research Hagop Kantarjian, MD, Chair and Professor in The University of Texas MD Anderson...
FDA Approves Assay That May Help Detect the Progression of Testicular Cancer
Abbott announced that the ARCHITECT AFP assay, which may help doctors detect the progression of testicular cancer as well as serious birth defects, has received FDA approval. The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay for the quantitative determination of...
Elekta Receives FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System
Elekta recently received 510(k) clearance from the FDA, allowing the company to begin shipping and installation of all components of the Versa HD system within the United States. The Versa HD radiation system, featuring high-precision beam shaping and tumor targeting, is capable of delivering...
SIDEBAR: Three Breakthrough Therapy Designations for Ibrutinib from the FDA
In February 2013, FDA granted Breakthrough Therapy Designations for ibrutinib as a monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma and as a monotherapy for the treatment of patients with Waldenström’s macroglobulinemia, both of which are also B-cell...
SIDEBAR: The Ethical Imperative of Clinical Equipoise
In her editorial about the RESONATE trial (page 1), Dr. O’Brien raises the issue of equipoise in this phase III clinical trial that compares the efficacy of ibrutinib and ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who are not appropriate...
Ibrutinib CLL Trial: Where Is the Equipoise?
The RESONATE trial is randomly assigning patients with refractory or relapsed CLL to either ofatumumab (Arzerra) or the investigational oral agent ibrutinib. Ofatumumab is an anti-CD20 monoclonal antibody like rituximab (Rituxan), but is more potent as a single agent. It was approved for refractory ...
FDA Warns about Potential Medication Errors
The FDA recently alerted health-care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine, also known as T-DM1 during preapproval clinical trials) in some medication-related electronic systems poses a risk of mix-up with...
Drug Approvals in Acute Myeloid Leukemia: Can We Do Better?
Forty years ago, President Richard Nixon announced a “war on cancer.” Some of that war’s first battles were won in the field of acute myeloid leukemia (AML) with two agents, cytarabine and daunorubicin, receiving U.S. Food and Drug Administration (FDA) approval based on their ability to produce...
Cancer Treatment Pioneers to Share Prize in Medicine and Biomedical Research
Peter C. Nowell, MD, Janet D. Rowley, MD, and Brian J. Druker, MD, have been named as the recipients of the 2013 Albany Medical Center Prize in Medicine and Biomedical Research, to be officially awarded May 17. The $500,000 award, given to those who have altered the course of medical research, is...
New Labeling for Reformulated OxyContin to Curb Abuse
The U.S. Food and Drug Administration has approved updated labeling for the reformulated painkiller OxyContin (controlled-release oxycodone hydrochloride). The new labeling will indicate that the drug has physical and chemical properties that make injection or snorting challenging. This new measure ...
Leading Investigators Honored for Outstanding Contributions to the Field of Oncology
Each year through its Special Awards Program, ASCO recognizes researchers, patient advocates, and leaders of the global oncology community who, through their work, have made significant contributions to enhancing cancer care. These recipients of ASCO’s highest, most prestigious awards collectively...
Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and...
Expert Point of View: Jan A. Burger, MD, PhD
Commenting on this study, Jan A. Burger, MD, PhD, Associate Professor in the Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, and first author of one of the ibrutinib studies presented at the 2012 Annual Meeting of the American Society of Hematology, said that...
Breakthroughs in Targeted Therapies for Breast Cancer Are Improving Patient Survival Rates
For more than 20 years, José Baselga, MD, PhD, has devoted his medical and scientific career to caring for breast cancer patients and the development of novel molecular targeted agents to treat the disease. From 1996 to 2010, he was Head of the Oncology Department of Vall d’Hebron University...
Tobacco Use in Cancer Patients: Often Overlooked but Critical to Address
One would hope that the importance of treatment for tobacco dependence would be well recognized as a cornerstone of standard care for cancer patients. However, a policy statement released by the American Association for Cancer Research (AACR) at its recent Annual Meeting revealed some surprising...
The Tissue Is the Issue: Choosing Therapy for Lung Cancer
The new guidelines from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology (CAP/IASLC/AMP) are a significant step toward personalized therapy of patients with lung cancer. More than 226,000 new patients per year are...
New Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitor Treatment
A new guideline for molecular testing to select lung cancer patients for treatment with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors has been jointly developed by the College of American Pathologists, International Association for the Study ...
FDA Approves Antiemetic Drug for New Line of Prefilled Generic Injectables
BD Rx Inc, announced that the FDA has approved metoclopramide hydrochloride, an injectable antiemetic, as the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables. BD Simplist prefilled injectables are designed to help improve...
Novel Cancer Immunotherapy Set to Enter Clinical Trials
PDS Biotechnology Corporation has announced that its Investigational New Drug application for the novel cancer immunotherapy agent PDS0101 has been granted by the FDA, allowing the agent to be evaluated in human patients. PDS0101 is based on the company’s Versamune nanotechnology vaccine platform....
Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma
Merck has announced that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that...
Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm of...
NCCN Clinical Practice Guidelines in Oncology: 2013 Updates
At the 18th Annual Conference of the National Comprehensive Cancer Network (NCCN), representatives of NCCN Guidelines panels presented two new sets of guidelines along with updates for several tumor types, summarized in this issue of The ASCO Post. New NCCN Guidelines for Survivorship “The...
On the Potential for Conflicts of Interest
In a recent issue of The ASCO Post, I counted 14 expert commentaries where the authority who wrote or was interviewed for the piece reported “no potential conflicts of interest.” I wondered how likely that was. We need to be clearer on the meaning of potential conflicts of interest. How often have...
How Is Sequestration Affecting Health Care?
The Budget Control Act of 2011, which calls for $1.2 trillion in federal funding cuts in national defense and nondefense programs, went into effect on March 1. The across-the-board cuts affect 21 agencies and programs directly involved in the health-care sector, including: Centers for Disease...
Sequestration's Impact on Cancer Care
On March 1, the deficit-budget mechanism known as sequestration took effect, triggering $85 billion in across-the-board cuts to most federal agencies over the remaining 7 months in fiscal year 2013. The total federal deficit reduction budget under the Budget Control Act of 2011 calls for $1.2...
Women at Increased Risk for Breast Cancer Should Be Offered Medications to Reduce Risk, Draft Recommendations Advise
Clinicians should engage in shared decision-making with women who are at increased risk of breast cancer about using medications, such as tamoxifen and raloxifene (Evista), to reduce risk, and should offer prescriptions to women considered at low risk for adverse effects from these medications,...
Utilizing the Power of Rapid Learning Health-care Systems to Improve Patient Care
Lynn Etheredge’s career in shaping national health-care and social policy spans more than 4 decades and four Presidential administrations. He was the lead analyst in the development of health insurance proposals for Medicare and Medicaid while working in the White House Office of Management and...
Peregrine Pharmaceuticals Reaches Agreement with FDA on Phase III Trial Design for Bavituximab in NSCLC
Peregrine Pharmaceuticals recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a phase III registration trial design of the company’s lead clinical immunotherapeutic candidate bavituximab in second-line non–small cell lung cancer (NSCLC). The trial...
Radium-223 Dichloride Approved for Patients with Castration-resistant Prostate Cancer
On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Radium-223 dichloride is an alpha-particle–emitting...
FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The FDA has approved erlotinib (Tarceva) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib was approved...
Impressive Results Shown for Immune Checkpoint Inhibitors: Anti-PD1 and Anti-PD-L1 Antibodies
Antibody-mediated blockade of the programmed death 1 protein (PD-1) and its ligand (PD-L1) resulted in potent and durable tumor regression and prolonged stabilization of disease in patients with advanced solid tumors, according to early data on these drugs presented at the 2013 ASCO Annual Meeting. ...
SIDEBAR: Understanding the PD-1/PD-L1 Pathway and Its Promise
Tumors can be recognized by the immune system, but they have multiple mechanisms for evading eradication by the immune system. The tumor microenvironment suppresses the immune response, partly because tumors can express molecules that inhibit immune responses. The cancer clinical trials summarized...
Expert Genitourinary Oncologist's Drive Led Her from Baghdad to the United States
Born in Baghdad, Iraq, renowned prostate and bladder cancer specialist Maha H. Hussain, MD, FACP, Professor of Medicine and Urology at the University of Michigan Comprehensive Cancer Center, remembers that she always wanted to become a doctor. She had strong role models in three uncles who were...
FDA Clears Multicenter Trial of Treatment for Hair Loss Related to Chemotherapy
The FDA has approved initiation of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. The trial is the second and final phase of study for the DigniCap System. A pilot study previously conducted by researchers at the University of California San...
FDA Approves Lenalidomide for Relapsed/Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration has approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade). Clinical Trial The approval was based on the results of...
Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation
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 May 29, 2013, trametinib (Mekinist) was approved by...
Orphan Drug Status Granted for Novel Targeted Therapy to Treat Rare Hematologic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Stemline Therapeutics’ SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug...
Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation
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 May 29, 2013, dabrafenib (Tafinlar) was approved for ...
SGX942 Gets Fast Track Status for Treatment of Oral Mucositis
The FDA has granted fast track designation to the SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in patients with head and neck cancer. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability ...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene...
FDA Approves New Silicone Gel-filled Breast Implant
The FDA recently approved the MemoryShape Breast Implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC. The FDA’s approval is based on 6 years of data from 955 women...
GM-CSF Boosts Survival Benefit of Ipilimumab in Metastatic Melanoma
For metastatic melanoma, the activity of ipilimumab can be boosted by the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF, Leukine), according to a phase II study that found the combination improved overall survival, vs ipilimumab alone. The results were presented at the 2013...
SIDEBAR: Expect Questions about Programmed Death Receptors
In today’s high-tech, sci-fi–loving culture, “programmed death receptor” seems like a term apt to stir up public interest, particularly when those receptors are being “targeted” by “agents.” In this case, however, the agents are antibodies that target programmed death 1 (PD-1) receptor and disable...
'Spectacular' Results with Immunotherapies in Melanoma Galvanize the Oncology Community
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. Much of the news about immunotherapy ...
Focus on the Society of Rhode Island Clinical Oncologists
Founded in 1994, just 1 year after ASCO launched the State/Regional Affiliate Program, the Society of Rhode Island Clinical Oncologists is one of ASCO’s oldest state affiliates. Like many other ASCO affiliates, the Providence-based group is facing a myriad of challenges, including ensuring...
