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Showing 2901 - 2950Cabozantinib in Metastatic Medullary Thyroid 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 November 29, 2012, cabozantinib (Cometriq) was...
Ezatiostat Gets Orphan Designation for Treatment of Myelodysplastic Syndrome
Telik, Inc, announced that its product candidate, ezatiostat hydrochloride (Telintra), has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndromes (MDS). Ezatiostat is an investigational agent in development for the treatment of MDS and idiopathic chronic...
Dune Medical Devices Receives FDA Approval for the MarginProbe System
Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively identify...
Cost of Cancer Drugs: What Price for What Benefit?
In 2011, national health-care spending in the United States was about $2.7 trillion, larger than the entire French national budget.1 U.S. national health-care spending is about 17% of the national gross domestic product. Total Medicare expenditures in 2011 were $549 million.2 In the debate about...
Treatment of HER2-positive Disease in 2013
From the initial discovery of the HER2 family of receptors in the mid-1980s to the present, a “wealth of riches” has been uncovered in terms of agents that can target pathways relevant to this aggressive breast cancer type, notes Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials...
ASH Highlights Included New Data in Myeloma, Lymphoma, and Leukemia, plus Studies of Mucositis and Graft-vs-Host Disease
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
Bevacizumab Approved as Combination Therapy for Metastatic Colorectal Cancer after Progression on First-line Bevacizumab Therapy
On January 23, 2013, the FDA approved bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab-containing...
We Need Gemtuzumab Available Again to Treat AML
The word “revival” signifies a renewed use or acceptance after a period of inactivity; similarly, the word “resurrection” refers to the concept of an entity coming back to life after death. In the past year, these terms have been used frequently by us (and others) in articles calling for the return ...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
The Challenges and Rewards of Neuro-oncology
Despite the extremely difficult clinical challenges posed by brain tumors, mortality rates in this disease have decreased somewhat over the past several decades due, in part, to advances in surgical techniques and therapies. The ASCO Post recently discussed contemporary issues in neuro-oncology...
Outcomes Comparable for Panitumumab and Bevacizumab in Metastatic Colorectal Cancer
In patients with KRAS wild-type metastatic colorectal cancer, outcomes were comparable whether patients received the epidermal growth factor receptor (EGFR) inhibitor panitumumab (Vectibix) or the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (Avastin). This was shown both in the...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide...
City of Hope Names Robert Stone, JD, as New Chief Executive Officer
After 10 years at City of Hope, in Duarte, California, former FDA acting Commissioner Michael A. Friedman, MD, has decided to retire from his position as Chief Executive Officer, and the Board of Directors has selected current President Robert Stone, JD, to assume the dual role of President and...
FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors
The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes...
Evaluating HER2 Status in Esophageal Cancers: FISH vs Immunohistochemistry
In screening patients with esophageal cancers for HER2 status, the relative efficiency of immunohistochemistry (IHC) vs fluorescence in situ hybridization (FISH) has been debated. Researchers from the Mayo Clinic compared the testing strategies and have proposed an algorithm that puts IHC up front, ...
Bendamustine/Rituximab Noninferior to Standard Chemotherapy for Advanced Indolent Non-Hodgkin and Mantle Cell Lymphomas
The combination of bendamustine (Treanda) and rituximab (Rituxan), or BR, was found to be noninferior to commonly used chemotherapy with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) or R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) in...
Pomalidomide in Previously Treated Multiple Myeloma
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 February 8, 2013, the immunomodulatory agent...
Apogenix Receives FDA Orphan Drug Designation for APG101 to Treat Myelodysplastic Syndromes and Initiates Clinical Phase I Study
Apogenix GmbH, a biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced that its lead compound, APG101 (Apocept), has been granted orphan drug designation from the FDA for the treatment of myelodysplastic syndromes (MDS)....
Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from FDA
Janssen Research & Development, LLC, and Pharmacyclics, LLC, announced that the FDA has granted Breakthrough Therapy Designations for the investigational oral agent ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory mantle cell lymphoma who have...
Colorectal Cancer: A Decade of Progress
The 2013 Gastrointestinal Cancers Symposium marked the 10th anniversary of the meeting. Richard M. Goldberg, MD, the Klotz Family Chair in Cancer Research, Professor of Medicine, and James Cancer Hospital Physician-in-Chief at The Ohio State University, looked back over the decade to highlight the...
T-DM1 for HER2-positive Metastatic Breast Cancer Receives FDA Approval
The FDA approved the antibodydrug conjugate ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. Ado-trastuzumab emtansine was...
Immunoassay Test May Help Identify Early Kidney Cancer
Renal cell carcinoma is the most common form of adult kidney cancer and the third most common urologic malignancy, accounting for about 2% of all malignancies and 2% of cancer-related deaths worldwide. It is also one of the most difficult cancers to detect and treat because it is usually found...
AACR Briefs Congressional Staffers on Importance of Continued Funding for Research
As we all now know, the start of the sequestration prescribed by the Budget Control Act of 2011 was delayed until March 1, 2013, by the American Taxpayer Relief Act of 2012. With Congress unable to strike a deal, the mandatory reductions in Federal spending were triggered on March 1. Those...
Implementing a National Cancer Clinical Trials System for the 21st Century
In March 2011, the National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. That workshop included...
Ado-Trastuzumab Emtansine in 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 On February 22, 2013, ado-trastuzumab emtansine...
Philips 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...
