Search Results
Your search for ,Fda matches 3728 pages
Showing 3401 - 3450FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. Trabectedin is a novel marine antineoplastic alkaloid with a unique mechanism ...
Daratumumab Approved in Multiple Myeloma
The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome...
FDA Approves Cobimetinib in Combination With Vemurafenib for Metastatic Melanoma
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval...
A Selfless Act
The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology (JCO). These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
ASCO Launches TAPUR to Assess the Off-Label Use of Targeted Therapies for Patients With Advanced Cancers
Two years ago, Richard L. Schilsky, MD, FACP, FASCO, Chief Medical Officer of ASCO, proposed a unique clinical trial concept during an educational session on the challenges of delivering precision medicine services in a community setting at ASCO’s Annual Meeting. The idea was to design a clinical...
The Role of Botulinum Toxin in Head and Neck Cancer
Head and neck cancer and its treatment can result in a variety of neuromuscular and musculoskeletal pain and functional sequelae. Commonly seen conditions in patients with the disease include neck pain and spasm, hemifacial spasm, trismus, dysphonia, dysarthria, neuropathic pain, and salivary...
Talimogene Laherparepvec for Treatment of Unresectable Cutaneous, Subcutaneous, and Nodal Melanoma Lesions
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 October 27, 2015, talimogene laherparepvec (Imlygic) was...
Ipilimumab in Adjuvant Treatment of Cutaneous Melanoma With Nodal Involvement
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 October 28, 2015, ipilimumab (Yervoy) was approved for adjuvant ...
The State of Progress in Hematologic Malignancies
The number of targeted therapies approved by the U.S. Food and Drug Administration (FDA) in the treatment of a variety of cancers, especially hematologic malignancies, continues to rise. In 2014 alone, 4 of the 10 new agents directed at discrete molecular targets approved by the FDA were for blood...
Lenvatinib in Refractory Thyroid Cancer: Survival Benefit or Not?
In the original phase III SELECT trial, no overall survival benefit was observed for lenvatinib (Lenvima) vs placebo in progressive radioactive iodine–refractory differentiated thyroid cancer. Overall survival was a secondary endpoint in that trial. However, in an updated analysis of SELECT, which...
Antoni Ribas, MD, PhD, Receives NCI Outstanding Investigator Award
UCLA Jonsson Comprehensive Cancer Center member Antoni Ribas, MD, PhD, has received a National Cancer Institute (NCI) Outstanding Investigator Award of $4.2 million in recognition of his research conducted in the development of new immunotherapies that utilize the human body’s own natural defenses ...
Nationally Regarded Oncology Nurse Practitioner, Mary Pazdur, RN, MSN, Remembered by Friends and Colleagues
Oncology nurse practitioner Mary Pazdur, RN, MSN, spent her professional life bettering the clinical care and outcomes of cancer patients, culminating in her career at the National Cancer Institute (NCI), in the Laboratory of Tumor Immunology and Biology, working with patients on cancer vaccine...
Yet Another Reason Why Dogs Are Our Best Friends
BookmarkTitle: Heal: The Vital Role of Dogs in the Search for Cancer CuresAuthor: Arlene WeintraubPublisher: ECW PressPublication date: October 13, 2015Price: $16.95; paperback, 240 pages Comparative oncology, a fairly recent addition to the ever-evolving world of cancer research, studies the...
Ixazomib 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 20, 2015, ixazomib (Ninlaro) was approved by the U.S....
Osimertinib for Metastatic EGFR T790M–Mutant Non–Small Cell Lung Cancer After EGFR Inhibitor Therapy
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 13, 2015, osimertinib (Tagrisso) was granted...
A Blueprint for Drug/Diagnostic Development: Expansion and Use of Curated Genetic Databases
In a continuation of a 2014 conference that explored regulatory considerations and strategies for next-generation sequencing, the Friends of Cancer Research, with support from Alexandria Real Estate Equities, Inc, Pasadena, California, met to discuss the issues and problems of coordinating drug and ...
FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC
The FDA approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC. Necitumumab is a recombinant human IgG1...
Cobimetinib in BRAF-Mutant Unresectable or Metastatic Melanoma in Combination With Vemurafenib
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 10, 2015, the U.S. Food and Drug Administration...
Trabectedin in Liposarcoma/Leiomyosarcoma: The Drug Is Approved, Now the Real Drug Development Begins!
Led by George Demetri, MD, of Dana-Farber Cancer Institute, Boston, expert medical oncology investigators from leading academic sarcoma centers and Janssen Pharmaceuticals employees performed a phase III trial in order to provide evidence for the U.S. Food and Drug Administration (FDA) approval of...
Nivolumab Receives Two FDA Approvals in November
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA)...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts with...
Olanzapine Significantly Reduces Chemotherapy-Induced Nausea and Vomiting
The addition of olanzapine to standard antiemetics significantly reduced chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, according to Rudolph M. Navari, MD, PhD, and colleagues. “As far as I know, this is the first trial that looked at no nausea as the ...
November Yields Record Number of FDA Approvals for New Oncology Drugs and Drug Indications
In 2014, the U.S. Food and Drug Administration (FDA) approved 9 new drugs and biologics in the treatment of cancer and added 10 notable new indications or formulations to existing drug labels, marking a year of significant progress in improving the quality of cancer care in the United States. So...
FDA Oncology New Drug/New Indication Approvals for 2015
The following new hematology/oncology agents and expanded indications were approved by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in 2015: Alectinib (Alecensa), an ALK inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive...
How to Help Mentees Succeed
Although formal mentoring programs in medical education were not launched in the United States until the late 1990s,1 today they are regarded as playing an essential role in the career development of medical trainees and have been associated with improvements in research, teaching, and patient...
Clinical Trial System Badly in Need of Overhaul, Say Panelists at Friends-Brookings Conference
Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer...
Breast Cancer Survivors May Expect More Extensive or Frequent Follow-up Testing Than Recommended
Patients who have been treated for breast cancer may overestimate the value of follow-up testing and may expect—or even ask for—more testing than recommended, Harold J. Burstein, MD, PhD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, told participants at the Lynn Sage...
Partnering Therapies for Estrogen Receptor–Positive Breast Cancer Requires Close Monitoring and Patient Communication
Partnering endocrine therapy with new targeted agents for women with estrogen receptor–positive breast cancer “changes the nature of endocrine therapy from something easily tolerated, with not a lot that you have to do as physicians to monitor it,” William J. Gradishar, MD, of the Robert H. Lurie...
Ibrutinib Bests Standard of Care for Elderly Patients With CLL
First-line treatment with the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) significantly reduced the risk of dying or disease progression compared with chlorambucil (Leukeran) in older treatment-naive patients with chronic lymphocytic leukemia (CLL) in the RESONATE-2 trial. At the time...
Andrew Seidman, MD, and Hope Rugo, MD, on Reducing Alopecia: FDA Approves New Device
Andrew Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss the recent approval of a cooling cap to reduce hair loss during chemotherapy.
S. Vincent Rajkumar, MD, on Multiple Myeloma: Newly Approved Drugs
S. Vincent Rajkumar, MD, of the Mayo Clinic, summarizes a special FDA-sponsored session on the three myeloma drugs that were approved this November––daratumumab, ixazomib, and elotozumab––and their current and future roles in treating the disease.
FDA Expands Pembrolizumab Label to Include Approval in Initial Treatment of Unresectable or Metastatic Melanoma
On December 18, 2015, the U.S. Food and Drug Administration (FDA) expanded the pembrolizumab (Keytruda) label to include approval of the drug for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or...
FDA Allows Marketing of Cooling Cap to Reduce Hair Loss During Chemotherapy
The U.S. Food and Drug Administration has cleared the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy for marketing in the United States. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of...
FDA Approves Alectinib for Advanced ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori). ...
FDA Approves Uridine Triacetate for Emergency Treatment of Fluorouracil or Capecitabine Overdose
The U.S. Food and Drug Administration (FDA) today approved uridine triacetate (Vistogard) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil (5-FU) or capecitabine, or who develop certain severe or life-threatening toxicities within...
ASH 2015: Updated Results of Phase III Tourmaline-MM1 Study of Ixazomib in Multiple Myeloma
In a study presented by Moureau et al at the 57th American Society of Hematology (ASH) Annual Meeting, ixazomib (Ninlaro), a recently approved oral proteasome inhibitor, significantly extended progression-free survival for patients with relapsed and/or refractory multiple myeloma (Abstract 727)....
Study Shows Abiraterone Acetate Is Useful Even in the Most Aggressive Prostate Cancers
In 1,048 prostate cancer patients previously treated with docetaxel, and 996 metastatic, castration-resistant patients, treatment with the androgen-lowering drug abiraterone acetate (Zytiga) led to longer overall disease control, even when a very high Gleason score indicated especially aggressive...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts...
FDA Approves Single-Agent Nivolumab for Previously Untreated BRAF Wild-Type Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today approved the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Clinical Trial Results The approval is based on data...
FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC
The U.S. Food and Drug Administration today approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC....
FDA Approves Nivolumab to Treat Advanced Kidney Cancer
The U.S. Food and Drug Administration today approved nivolumab (Opdivo) to treat patients with metastatic renal cell carcinoma who have received a prior antiangiogenic therapy. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2,...
FDA Approves Ixazomib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy. “As we learn more about the underlying biology of multiple myeloma, we are encouraged ...
Users of Smokeless Tobacco Have Higher Levels of Nicotine and Toxicant Exposure Than Cigarette Smokers
A study analyzing data from a large, nationally representative U.S. health survey population comparing biomarkers of tobacco exposure in smokeless tobacco users and cigarette smokers has found the exclusive smokeless tobacco users have higher observed levels of exposure to nicotine and a...
FDA Approves Daratumumab for Patients With Previously Treated Multiple Myeloma
Today the U.S. Food and Drug Administration granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome ...
FDA Approves Osimertinib for EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer After Progression on Prior EGFR-Blocking Therapy
The U.S. Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non–small cell lung cancer (NSCLC). Osimertinib (Tagrisso) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation ...
FDA Approves Cobimetinib in Combination With Vemurafenib for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) approved cobimetinib (Cotellic) to be used in combination with vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma, with the BRAF V600E or V600K mutation. “As we continue to advance our knowledge of tumor biology, we have...
Few Oncology Drugs Approved on Surrogate Endpoints Currently Have Evidence of Survival Benefit
In a study reported in a research letter in JAMA Internal Medicine, Kim and Prasad found that few oncology drugs receiving FDA approval on the basis of surrogate endpoints currently have evidence of an overall survival benefit. In the study, all approvals from January 1, 2008, through December 31, ...
Stool DNA Test Accurate in Screening for Colorectal Cancer in Alaska Native People
Cologuard stool DNA testing for colorectal cancer was found to be an accurate noninvasive screening option for Alaska Native people, a population with one of the world's highest rates of colorectal cancer, concluded researchers from the Alaska Native Tribal Health Consortium and Mayo Clinic. The...
FDA Approves Adjuvant Ipilimumab to Reduce the Risk of Melanoma Returning After Surgery
The U.S. Food and Drug Administration has expanded the approved use of ipilimumab (Yervoy) to include a new use as adjuvant therapy for patients who have cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm and have undergone complete resection, including total...
FDA Approves Talimogene Laherparepvec for Unresectable Recurrent Melanoma
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for talimogene laherparepvec (Imlygic), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma...
