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Showing 2701 - 2750New Biomarker Test Cleared to Evaluate Ovarian Cancer Likelihood
Fujirebio Diagnostics announced that it has received 510(k) clearance from the FDA to market the company’s HE4 Test in an algorithm called ROMA to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding...
FDA Approves Denosumab to Increase Bone Mass in Patients with Cancer
Denosumab (Prolia) recently received FDA approval as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. Pivotal Trials The approvals were based...
SIDEBAR: A Snapshot of I-SPY 2
With principal investigator Laura Esserman, MD, MBA, of the University of California, San Francisco, and co–principal investigator Donald Berry, PhD, of MD Anderson Cancer Center, I-SPY 2 will screen up to 12 different drugs in neoadjuvant therapy for breast cancer over the course of the trial. In...
Can Bayesian Design Streamline Our Sluggish Clinical Trial System?
The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...
International Prostate Cancer Studies Report Inroads in Managing Bone Metastases
Treatment and prevention of bone metastases in patients with prostate cancer is coming of age, according to several studies presented at the European Multidisciplinary Cancer Congress (ECCO/ESMO/ESTRO). Among the most impressive studies reported was an international phase III trial of radium-223,...
Adjuvant Treatment Still Standard in Melanoma, but New Drugs Prolong Life in Metastatic Setting
At the Best of ASCO® Miami meeting, Omid Hamid, MD, The Angeles Clinic and Research Institute (www.theangelesclinic.org), Los Angeles, California, reviewed abstracts that received a great deal of attention at this year’s Annual Meeting—the new treatments for metastatic melanoma. He also described...
SIDEBAR: Using Axitinib in Advanced Renal Cell Carcinoma
With a new tyrosine kinase inhibitor joining the armamentarium, the question is how to optimize targeted agents for advanced renal cell carcinoma. The AXIS trial demonstrated strong clinical activity for axitinib, which was superior to second-line sorafenib (Nexavar) and generally appears most...
Novel Management Strategies Assessed in Renal Cell and Prostate Cancers
At the Best of ASCO Miami meeting, William Oh, MD, of the Tisch Cancer Institute, Mount Sinai School of Medicine, New York, described new trends and remaining questions in the management of renal cell and prostate cancers. Axitinib vs Sorafenib in Second-line RCC Axitinib, a potent and selective...
Multiple Myeloma Research Spotlights Treatment Concerns and Advances
Myeloma data reported at this year’s ASCO meeting raise concern about the safety of a mainstay class of drugs in this disease, while also hinting at good efficacy of some novel drugs and approaches, according to William I. Bensinger, MD, of the Fred Hutchinson Cancer Research Center, Seattle....
Tobacco Remains the Dominant Global Risk Factor Underlying Cancer
Despite clear evidence that tobacco causes at least 18 types of cancer, as well as many other diseases, many people all over the world smoke or chew tobacco, or are exposed to secondhand smoke. Although smoking among Americans has declined slowly but steadily over the past 40 years, it remains the...
Bevacizumab Labeling Revised to Include New Risks
The FDA recently announced changes made to the bevacizumab (Avastin) package insert regarding new safety concerns. These changes include the following: A new Warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and...
Gel for Blood Vessel Surgery Approved
The FDA has approved LeGoo (PluroMed Inc, Woburn, Mass), a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops. LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels....
FDA Issues Safety Announcement on Dasatinib
The FDA is warning the public that the leukemia drug dasatinib (Sprycel) may increase the risk of pulmonary arterial hypertension (PAH). Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label. In reported cases, patients developed PAH after...
Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer
Indication Crizotinib (Xalkori) is an oral inhibitor of receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-Met), and recepteur d’origine nantais (RON). In August 2011, the FDA granted the drug accelerated approval for the treatment of...
AACR Issues Landmark Report on Cancer Progress
At a recent press conference in Washington, DC, the American Association for Cancer Research (AACR) assembled luminaries from the cancer research and care communities to discuss the salient points of the association’s newly released progress report on the current and future state of cancer research ...
FDA Commissioner Announces Decision on Bevacizumab
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will still remain on the market as an...
FDA Approves Cetuximab to Treat Metastatic Head and Neck Cancer
On November 7, the FDA approved cetuximab (Erbitux) in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck. The approval was based primarily on...
Biosimilars in Cancer Treatment: What Should the Oncology Community Expect?
Alternative versions of biologic agents, ie, “biosimilars,” will presumably be getting the green light by the FDA, giving oncologists more choices for treatments that come at lower costs to patients and society. The FDA plans to issue its guidance on biosimilars by the end of this year, paving the...
Test for AML Prognosis Cleared by FDA
Abbott announced today it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML) Abbott’s Vysis EGR1 FISH Probe Kit, the third Abbott fluorescence in situ hybridization (FISH) assay approved or...
VGX-100 Investigational New Drug Application Approved
The Australian biotechnology company Circadian Technologies announced that its subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the FDA to initiate clinical trials of VGX-100. The first phase I trial will study VGX-100 in patients with a...
FDA Approves Molecular Test to Detect HPV
Gen-Probe recently announced that the FDA has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe’s fully...
SIDEBAR: White House Issues Executive Order on Drug Shortage
On October 31, President Barack Obama issued an executive order instructing the FDA to broaden reporting of potential drug shortages, expedite reviews of applications to begin or modify production of these drugs, and provide more information to the Justice Department about possible cases of...
Chemotherapy Drug Shortages: A Preventable Human Disaster
The issue of chemotherapy drug shortages continues with no end in sight. Many heartfelt human interest stories have been told on television, in newspapers, and even to Congress, but the bottom line is that little, if any, action has been taken. Uniquely American Problem News of the generic...
Important Lessons for Oncology from the Front Lines of the AIDS Pandemic
On June 5, 1981, the CDC issued a warning about a rare type of pneumonia discovered among a small group of young gay men in Los Angeles, later determined to be AIDS-related, ushering in the HIV/AIDS epidemic. Early on, AIDS-related malignancies brought the oncology community into this formidable...
510(k) Clearance Granted for OncoTrac
Translational Sciences Corporation announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software. OncoTrac is designed for efficient quantitative assessment of treatment response of metastatic tumors including those of the breast, lung,...
FDA Approves First Drug to Treat Myelofibrosis
The FDA has approved ruxolitinib (Jakafi), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. Myelofibrosis is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the...
Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its...
New Drug Approved to Treat Acute Lymphoblastic Leukemia
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed...
2011 in Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2011. Asparaginase Erwinia chrysanthemi (Erwinaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in patients who have...
Optimizing HER2-directed Therapy in the Clinic
Seminal research in the treatment of HER2-positive breast cancer has been led by Edith A. Perez, MD, the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic, Jacksonville, Florida. The ASCO Post asked Dr. Perez to share her approach to HER2-directed therapy. Testing...
Breast Cancer Experts Voice Opinion and Express ‘Disappointment’ over FDA Decision
Gabriel N. Hortobagyi, MD, Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, said he was “disappointed but not surprised” at the FDA decision to withdraw the bevacizumab (Avastin) indication in breast cancer. “Once the FDA put this in the hands of ODAC, ...
FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will remain on the market as an...
New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck
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. Cetuximab (Erbitux) was recently approved by the FDA for use in...
Update on Novel Treatments for Peripheral T-cell Lymphoma
At the recent Pan-Pacific Lymphoma Conference in Kauai, Hawaii, Julie M. Vose, MD, from the University of Nebraska Medical Center, Omaha, discussed novel treatments for peripheral T-cell lymphoma (PTCL). PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin...
Advances in Lung Cancer Treatment Show Incremental Benefits, but Room for Improvement Remains
Newer therapies for the treatment of non–small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) were discussed at the Chemotherapy Foundation Symposium. More inroads have been made in improving outcomes for patients with NSCLC than for those with SCLC, but there is still room for...
Highlights of Bladder Cancer Research Include Novel Agents and New Approach to Identifying Biomarkers
It is an exciting time for researchers involved in developing new therapies for bladder cancer. More agents are in clinical development, drugs with novel mechanisms and novel trial designs are being implemented, and functional collaboration is occurring in the field, according to Noah Hahn, MD,...
Ruxolitinib for Myelofibrosis Therapy: A Good Start but a Long Road Ahead
Following a priority review process for orphan diseases, ruxolitinb (Jakafi) recently became the first drug to receive FDA approval for the treatment of intermediate- and high-risk myelofibrosis. Discovery in 2004 of the JAK2V617F mutation in a significant proportion of patients with...
First Genomic-based Pediatric Trials Launched in Neuroblastoma
Last November, Dell announced it was donating an initial $4 million including cloud-computing technology to speed up development of personalized medicine trials for children with neuroblastoma and other pediatric cancers. According to the American Cancer Society, about 650 children under the age of ...
Conquer Cancer Foundation Grantees Advance Cancer Care
Each year, the Conquer Cancer Foundation of ASCO funds Young Investigator Awards (YIAs) and Career Development Awards (CDAs). These research grants provide start-up funding for young physician-scientists as they embark on cancer research careers. Clearly, the programs are working: Six of the top...
NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy
“Many new frontiers exist in integrative medicine,” NIH Director Francis Collins, MD, PhD, stated in his keynote address at the Eighth International Conference of the Society for Integrative Oncology (SIO) in Cleveland. “The evidence is overwhelming that these approaches are being used by many...
Estrogen for Vulvovaginal Atrophy in Breast Cancer: Debate Continues
Vulvovaginal atrophy is a concern for the majority of patients with breast cancer, not only because of its physical and psychosexual consequences, but because the optimal treatment—estrogen replacement—is controversial. Patients and physicians alike remain concerned that external estradiol may...
Sipuleucel-T Should Be Used Early in Metastatic Castrate-resistant Prostate Cancer, before Chemotherapy
When sipuleucel-T (Provenge) was approved by FDA in April 2010, it was the first vaccine to be approved as a treatment for prostate cancer and was hailed as a major advance. Although sipuleucel-T is now reimbursable by Medicare, some physicians are not clear about when to use it, and patients who...
Package Inserts Revised for IV Methotrexate Products
The FDA has approved changes to the package inserts for methotrexate products for intravenous administration. Additional information regarding concomitant proton pump inhibitor (PPI) therapy has been added to the Warning section of the label. Specifically, the new text includes the following...
Investigational New Drug Application Filed for ONT-10
Oncothyreon Inc announced the filing of an Investigational New Drug (IND) application with the FDA for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA’s review of the IND, Oncothyreon expects to initiate a phase I trial. ONT-10 is a therapeutic vaccine...
New System for Cervical Cancer Screening Approved
Hologic announced that the FDA has approved its Cervista HTA (high throughput automation) system for use with its previously approved Cervista human papillomavirus (HPV) HR test. The Company’s Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test,...
ODAC Backs Axitinib for Kidney Cancer
The FDA’s Oncologic Drugs Advisory Committee voted 13-0 that Pfizer’s drug axitinib (Inlyta) had a favorable benefit-risk profile for patients with advanced renal cell carcinoma after initial treatment has failed. The FDA is due to make a final decision in the first half of 2012. Panelists said the ...
Bevacizumab Breast Cancer Indication Rescinded: What Are the Downstream Implications?
Leading up to FDA’s resolution to revoke the breast cancer indication for bevacizumab (Avastin), the debate over the drug’s clinical value was imbued with contentious ideologic overtones, which culminated in a 2-day public hearing that exposed deep divisions not only in the scientific community,...
FDA Approves Imatinib for Expanded Use in GIST
The FDA has granted imatinib mesylate (Gleevec) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The new approval also highlights an increase in overall patient survival when the drug is taken for 36 months rather than...
Integration of QOPI® Helps Michigan Insurer Earn ‘Best of Blue’ Award
By working to improve oncology care in practices in Michigan through integration of ASCO’s Quality Oncology Practice Initiative (QOPI) into its Physician Group Incentive Program, Blue Cross Blue Shield of Michigan (BCBSM) has been selected as a 2011 “Best of Blue Clinical Distinction Award” winner...
Is Gemtuzumab a Therapeutic Option in Older Patients with Acute Myeloid Leukemia?
Previous studies of gemtuzumab ozogamicin (Mylotarg) had variable results in acute myeloid leukemia (AML). Before trials reported at the 2011 ASH Annual Meeting, two major studies had compared chemotherapy with or without gemtuzumab in patients with AML, said Martin Tallman, MD, Chief of the...
