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Showing 2601 - 2650ASCO Commends Confirmation of Robert M. Califf, MD, as FDA Commissioner
“We commend the U.S. Senate for confirming Robert M. Califf, MD, as Commissioner of the Food and Drug Administration (FDA). Dr. Califf brings extraordinary expertise and vision to this position and we are confident that his appointment will positively impact cancer care. “Dr. Califf's...
100% of NCI-Designated Cancer Centers Endorse the Promotion of the HPV Vaccination for Cancer Prevention
All National Cancer Institute (NCI)-designated cancer centers have united to support human papillomavirus (HPV) vaccination (see below). A team of HPV experts drafted a consensus statement that advises widespread use of HPV vaccines to prevent cancer. HPV causes cancer of the cervix, anus, and...
Mistletoe
The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and...
FDA Approves Palbociclib in Combination With Fulvestrant in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
On February 19, 2016, the U.S. Food and Drug Administration approved palbociclib (Ibrance) in combination with fulvestrant for the treatment of women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer with...
Oncology Drug Approvals: Year in Review
In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to...
Emory and Winship Announce Sagar Lonial, MD, as Hematology and Medical Oncology Department Chair
Sagar Lonial, MD, an internationally renowned expert in the biology and treatment of patients with multiple myeloma, has been named Chair of the Department of Hematology and Medical Oncology within Emory University School of Medicine and Winship Cancer Institute. Dr. Lonial assumes this role...
Management of Advanced Lung Cancer in the Elderly: A Reason to Rejoice or a Cause for Concern?
There is ample evidence to suggest that older adults with a good performance status (0 or 1) with advanced non–small cell lung cancer (NSCLC) should be treated with combination chemotherapy akin to younger patients.1,2 However, older adults comprise a heterogeneous group that has been...
Eribulin Improves Overall Survival vs Dacarbazine in Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in The Lancet, Schöffski et al found that eribulin improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received at least two prior systemic treatments for advanced disease. Outcome in the subgroup with...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
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. On December 11, 2015, alectinib (Alecensa) was granted...
Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma
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. On December 18, 2015, approval of the programmed cell death...
A Pioneering Oncologist’s Roadmap Forward
Bookmark Title: The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable—and How We Can Get There Authors: Vincent T. DeVita, Jr, MD, and Elizabeth DeVita-Raeburn Publisher: Farrar, Straus and Giroux Publication date:...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra), a CD20-directed cytolytic monoclonal antibody, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia...
Defibrotide Under Review for Transplant-Related Complication
A potentially fatal complication of hematopoietic stem cell transplantation may be reversed with the use of a novel drug currently under priority review at the U.S. Food and Drug Administration (FDA). Hepatic veno-occlusive disease/sinusoidal obstruction syndrome is usually a serious complication...
ASCO Names Cancer Advance of the Year: Immunotherapy
At a Capitol Hill briefing today, ASCO announced immunotherapy as the top cancer advance of the year. Recent breakthroughs in immunotherapy—along with almost 60 other important cancer research advances—are described in ASCO's just-released report, Clinical Cancer Advances 2016: ASCO's...
Studies Confirm and Extend the Benefits of Ixazomib in Multiple Myeloma
Patients with multiple myeloma now have access to an all-oral regimen, with the recent approval of the oral proteasome inhibitor ixazomib (Ninlaro) in previously treated patients. New pairings for the drug in relapsed/refractory and newly diagnosed patients are being studied, with investigators...
New Appointments Within FDA’s Office of Hematology and Oncology Products
The U.S. Food and Drug Administration (FDA) recently announced the appointment of an Acting Deputy Office Director and an Associate Director of Clinical Science in its Office of Hematology and Oncology Products (OHOP). Acting Deputy Office Director Amy E. McKee, MD, was recently announced as the...
Pembrolizumab Label Updated With New Clinical Trial Information
Late in 2015, the U. S. Food and Drug Administration (FDA) expanded the label for pembrolizumab (Keytruda), a humanized antibody, to include the initial treatment of patients with unresectable or metastatic melanoma. Previously, pembrolizumab had received accelerated approval in patients with...
Two Contenders for Second-Line Treatment of Advanced Renal Cell Carcinoma
Options for second-line therapy of advanced/metastatic renal cell carcinoma are expanding. Updates from the CheckMate 025 and METEOR trials presented at the 2016 Genitourinary Cancers Symposium solidify the value of both nivolumab (Opdivo, an immune checkpoint inhibitor) and cabozantinib...
John Smyth, MD, on The Current State of Cancer Research and Treatment: The European Perspective
John Smyth, MD, of the University of Edinburgh, discusses oncology from an international point of view.
Winning the Battle at the Front Lines: Lenalidomide Plus Rituximab— A Promising Initial Treatment for Mantle Cell Lymphoma
Mantle cell lymphoma is a pernicious, incurable disease. Front-line therapies for this disease are not currently standardized; however, novel therapies for relapsed or refractory mantle cell lymphoma can ideally be translated into beneficial treatments for newly diagnosed patients, as clearly...
E-Cigarette Advertisements Reach Nearly 7 in 10 Middle and High School Students
About 7 in 10 middle and high school students—more than 18 million young people—see e-cigarette advertising in stores, online, in newspapers and magazines, or on television and in movies, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report. E-cigarette ads use...
The Evolving Treatment Landscape of ALK-Positive NSCLC
Since the initial discovery of ALK rearrangement in non–small cell lung cancer (NSCLC) in 2007,1 small molecule tyrosine kinase inhibitors of ALK have transformed the course of disease for those patients with ALK-rearranged (ie, ALK-positive) NSCLC. Crizotinib (Xalkori), a multitargeted tyrosine...
Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity
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. On December 11, 2015, uridine triacetate (Vistogard) was approved...
Immunotherapy for Breast Cancer: Early Lackluster Study Results yet Promise Remains
Immunotherapy is at the forefront of exciting new approaches to cancer, with excellent and long-lasting responses in metastatic melanoma and non–small cell lung cancer (NSCLC) and several immunotherapy agents now approved for those malignancies by the U.S. Food and Drug Administration (FDA). The...
Venetoclax May Prove to Be Strong Weapon Against Poor-Prognosis Chronic Lymphocytic Leukemia
Venetoclax, the latest entry into the field of treatment of chronic lymphocytic leukemia (CLL), is a powerful investigational therapy that promises to fill an important niche: treatment of high-risk relapsed/refractory patients with deletions of 17p. Nearly 80% of patients with relapsed/refractory...
Elotuzumab 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. On November 30, 2015, elotuzumab (Empliciti) was approved for...
Multiple Myeloma in 2015: A Year for the Record Books
Few malignancies have received as much attention, in the way of newly approved drugs, as multiple myeloma did in 2015. In November alone, 3 new agents were approved, bringing the total to 4 for the year as part of a record 7 approvals and to 16 regulatory approvals over the past 12 years. Speakers...
FDA Approves Eribulin Mesylate in Unresectable or Metastatic Liposarcoma
The U.S. Food and Drug Administration today approved eribulin mesylate (Halaven), an antimicrotubular antineoplastic agent, for the treatment of unresectable or metastatic liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug....
100% of NCI-Designated Cancer Centers Endorse the Promotion of the HPV Vaccination for Cancer Prevention
All National Cancer Institute (NCI)-designated cancer centers have united to support human papillomavirus (HPV) vaccination. A team of HPV experts drafted a consensus statement that advises widespread use of HPV vaccines to prevent cancer. HPV causes cancer of the cervix, anus, and throat. The HPV ...
Nivolumab Plus Ipilimumab Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Bristol-Myers Squibb announced on January 23 that the U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic...
FDA Approves Carfilzomib as Single Agent or in Combination in Relapsed/Refractory Multiple Myeloma
Amgen announced on January 21 that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application of carfilzomib (Kyprolis) for injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration today approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the...
FDA Issues Revised Draft Guidance on Financial Disclosure by Clinical Investigators
The FDA recently issued a draft guidance on financial disclosure by clinical investigators, intended to assist researchers, industry, and FDA staff in interpreting and complying with regulations found in the Code of Federal Regulations Title 21, Part 54. The draft is being distributed for comment...
Trabectedin New Drug Application Withdrawn
Centocor Ortho Biotech Products, LP, announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin (Yondelis) for the treatment of women with recurrent ovarian cancer. The withdrawal is based on the FDA’s recommendation that an additional phase III study be conducted to ...
FDA Approves Sunitinib for Pancreatic Neuroendocrine Tumors
The FDA approved sunitinib (Sutent) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have metastasized. This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved...
New Drug Application Submitted for Vemurafenib in Melanoma
Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has...
Opinion: The FDA–Pharmaceutical Industry Complex
On January 17, 1961, President Dwight D. Eisenhower, in his farewell address to the nation, coined the term “the military-industrial complex.” His purpose was to warn of the inefficiencies that could result from such a relationship, which would imperil the strength of our military and the safety of ...
Changes Introduced to Better Inform Consumers about Sunscreen
The FDA announced that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The...
Test Approved to Help Determine Candidacy for Trastuzumab
The FDA has approved a new genetic test that will help health-care professionals determine whether women with breast cancer are HER2-positive and, therefore, candidates for trastuzumab (Herceptin). The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in...
Understanding Crizotinib, 1 Year after High-profile Presentation
The findings from a phase I study of crizotinib in non–small cell lung cancer (NSCLC) were presented in a Plenary Session at the 2010 ASCO Annual Meeting—an unusual event, since such early-phase data are not generally the topic of plenary sessions. The study showed that a majority of mostly...
Novel Agents Improve Survival in Patients with Metastatic Melanoma
Novel treatments for metastatic melanoma dominated the buzz at the 2011 ASCO Annual Meeting and across the major news outlets, with reports that two agents with entirely different mechanisms of action could extend survival. The studies’ inclusion in the ASCO Plenary Session attested to the...
Cervical Cancer Screening Study Should Reassure Physicians and Patients that a 3-Year Screening Interval Is Safe and Effective
Results of a large-scale cervical cancer screening study using concurrent human papillomavirus (HPV) and Pap testing should “reassure” women over 30 who test negative for HPV and have normal Pap tests that “it is extremely safe to go 3 years” before being tested again, Barnett S. Kramer, MD, MPH,...
My First of Many ASCO Meetings
In June, I attended my first ASCO Annual Meeting. Although I have been practicing and teaching urology for 35 years with a specific interest in genitourinary oncology and I have attended dozens of national meetings, the ASCO Annual Meetings were not on my radar. Focus on the Patient The...
FDA Issues Updated Safety Data on Silicone Gel–filled Breast Implants
The FDA has released a report updating the clinical and scientific information for silicone gel–filled breast implants, including preliminary safety data from studies conducted by the manufacturers (Allergan and Mentor) as a condition of their November 2006 approval. While the report confirms...
First Fentanyl Nasal Spray Approved for Cancer Breakthrough Pain
The FDA has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. This marks the first FDA product approval for...
Novel JAK Inhibitor May Be an Option for Patients with Myelofibrosis
A new approach to treating myelofibrosis appears to be paying off, according to several studies presented at the 2011 ASCO Annual Meeting. Treatment with a novel JAK inhibitor called ruxolitinib demonstrated significant and sustained improvement in splenomegaly and overall quality of life,...
ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer
In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory...
Final Decision on Sipuleucel-T
The Centers for Medicare & Mediaid Services (CMS) issued a final decision to cover FDA-approved indications of sipuleucel-T (Provenge) in prostate cancer, calling the treatment “reasonable and necessary.” The CMS final decision assures provider reimbursement of sipuleucel-T for Medicare...
Exemestane Prevents Invasive and Preinvasive Breast Cancers in MAP.3 Trial
The aromatase inhibitor exemestane, taken for 5 years, significantly reduced invasive and preinvasive breast cancers in postmenopausal women at increased risk for the disease, in the large Canadian NCIC CTG MAP.3 randomized trial. Results of the trial were presented at the recent ASCO Annual...
Despite Advances, Little Overall Improvement Seen in Treatment of Older Adults with AML
The outcome of treatment of older adults with acute myeloid leukemia (AML) remains unsatisfactory, although certainly not a totally futile exercise. Patients satisfying the entry criteria for cooperative group clinical trials can be expected to have complete remission rates of 50% to 55%, with...
