Search Results
Your search for ,Fda matches 3728 pages
Showing 2651 - 2700SIDEBAR: Expect Questions from Your Patients
Drugs for the treatment of prostate cancer have been in the news because of recent approvals by the FDA, the costs connected with their use, and associated improvements in survival.1 More recently reported was the decision to allow Medicare coverage of sipuleucel-T treatment for men who met the FDA ...
Optimizing Treatment for Advanced Prostate Cancer Requires Shifting Focus from Individual Drugs to Integrated Therapies
Newer drugs, including sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone (Zytiga), can extend survival modestly and ease symptoms for men with advanced prostate cancer. Maximizing the benefit to patients will require shifting the focus from developing individual drugs to developing...
FDA Outlines Oversight of Mobile Medical Applications
The FDA is seeking input on its proposed oversight approach for mobile medical applications (“apps”) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications, and will not regulate the...
New Safety Information Reported for 5-alpha Reductase Inhibitors
The FDA announced that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer. This risk appears to be low, but health-care...
Oncology Community Briefs Members of Congress and Calls for Action
ASCO and seven other oncology organizations held a Capitol Hill briefing in July and explained to nearly 200 members of Congress and their staffs how widespread cancer drug shortages are creating “a crisis in care.” According to the University of Utah Drug Information Service, the number of drug...
ODAC Recommends Accelerated Approval for Brentuximab
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant...
FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies
The FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft ...
Updated Drug Label Approved for Pioglitazone after Safety Review
The FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be...
Circulating Tumor Cell Assay Shows Potential for Predicting Prognosis in Head and Neck Carcinoma
According to the NCI, an estimated 49,260 new cases of oral cavity, pharyngeal, and laryngeal cancers occurred in the United States in 2010, and approximately 11,480 deaths were attributed to these cases. It is estimated that 95% or more of these cases are squamous cell carcinomas. Currently, the...
Congressional Hearing Highlights Oncology Drug Shortages
Some oncology drugs are in such short supply that the situation is now critical, with almost 200 drugs affected—triple that of 2003. This was the background described by speakers at a July 2011 congressional briefing sponsored by the Association of Community Cancer Centers (ACCC), ASCO, and other...
Fixing the Drug Shortage: It’s About Time
I have spent the past 30 years trying to improve the results of treatment for advanced cancer. I had the privilege of working with Sir Michael Peckham when the late Professor Tim McElwain and he were evolving variants of the PVB (cisplatin, vinblastine, bleomycin) and PEB (cisplatin, etoposide,...
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the...
Integrative Oncology Modalities Supported by Varying Levels of Evidence, but More Research Needed Overall
Over the past couple of decades, unregulated nonstandard oncology approaches have gained growing popularity among cancer patients. The relatively new field of integrative oncology was established to promote a more holistic and multidisciplinary approach to cancer care and to encourage scientific...
Radium-223 Chloride Gets Fast Track Designation
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with...
FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic...
Action Date Set for Denosumab Supplemental Application
Amgen announced that the FDA will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012, for the supplemental Biologics License Application to expand the indication for denosumab (Xgeva) to treat men with castrate-resistant prostate cancer to reduce the risk of developing...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and...
Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
Oncology Drug Shortage: An Unintended Consequence of the Medicare Modernization Act and Free-market Forces?
Oncology has a drug shortage problem, and the FDA says that it is getting worse. Drug shortages are not a new phenomenon, but over the past few years we have seen a rapidly growing number of shortfalls that are limiting providers’ ability to care for their patients. In 2004, the FDA reported 58...
Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma
Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...
Important Benefit for Small Population Is a Major Milestone in Lymphoma
The approval of brentuximab vedotin (Adcetris) is a major milestone for the treatment of patients with relapsed Hodgkin lymphoma and anaplastic large cell lymphoma. It represents an excellent example of personalized cancer therapy. Patients are preselected based on a predictive biomarker that is...
FDA Approves Brentuximab Vedotin in Two Lymphoma Indications
The antibody-drug conjugate brentuximab vedotin (Adcetris) was granted accelerated approval on August 19 for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin is the first new drug to be approved in Hodgkin lymphoma in more...
Cancer Information on Wikipedia as Accurate as on PDQ but Harder to Understand
A comparison of cancer information on Wikipedia and the patient version of information on the NCI’s Physician Data Query (PDQ) “found that although Wikipedia had similar accuracy and depth to the PDQ, the written style was more complex and thus might be less understandable to patients.” According...
FDA Announces Changes in Drug Center’s Oncology Office
The FDA recently announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
New 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,...
