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Showing 3451 - 3500Clinical 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...
National Coalition for Cancer Survivorship Honors Richard Pazdur, MD, and Ellen Goodman
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. Special guest Robert M. Califf, MD, Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA),...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration today approved the chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. This treatment is approved for patients who previously received...
Statement From AACR CEO Margaret Foti, PhD, MD (hc), on Vice President Biden’s Call for More Cancer Research
Margaret Foti, PhD, MD (hc), CEO of the American Association for Cancer Research (AACR), issued the following statement regarding Vice President Joe Biden’s call for a “moon shot” to end cancer: “We extend our deepest sympathy to Vice President Biden and his family for the...
FDA Approves Liposomal Irinotecan for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration today approved irinotecan liposome injection (Onivyde), in combination with fluorouracil (5-FU) and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. According to the National...
Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia
Pfizer announced that the investigational antibody-drug conjugate inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). The Breakthrough Therapy designation was based on the results of the phase III...
FDA Approves Use of Nivolumab in Advanced Nonsquamous Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the...
FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The U.S. Food and Drug Administration (FDA) today approved an expanded indication for the Optune tumor treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include...
ASCO Endorses CHEST Guideline on Treatment of Small Cell Lung Cancer
As reported in the Journal of Clinical Oncology, ASCO has endorsed the current American College of Chest Physicians (CHEST) guideline on treatment of small cell lung cancer, released in 2013. After review of evidence from an updated literature search covering 2011 to March 2015, an ASCO...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell...
ECC 2015: Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma: Results of the IMvigor 210 Study
At the 2015 European Cancer Congress in Vienna, Austria, early results were announced (Abstract 21LBA) from a pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (anti–PD-L1; MPDL3280A) in people with locally advanced or metastatic urothelial...
FDA Grants Accelerated Approval to Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type, Unresectable, or Metastatic Melanoma
On September 30, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type, unresectable, or metastatic melanoma. The FDA is scheduled to make a decision on ...
Preclinical Study Shows Starving Cancer Cells of Cholesterol May Inhibit Tumor Growth and Improve Drug Sensitivity
Drugs that target key proteins involved in cholesterol metabolism could represent a promising new treatment strategy for a broad range of cancers, according to research by Fox Chase Cancer Center investigators. The study, published by Gabitova et al in Cell Reports, reveals that deficiency in the...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration today approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. The new agent is an oral combination of...
AACR’s Cancer Progress Report Details Major Advances in Cancer and Rising Costs of Treatment
The American Association for Cancer Research (AACR) 2015 Cancer Progress Report highlighted the accelerated pace of the number of U.S. Food and Drug Administration (FDA)-approved targeted therapies over the past 5 years, which reached 52 this year; the dramatic increase in the 5-year survival rate...
FDA Grants Priority Review to Ixazomib for Patients With Relapsed/Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced. The New Drug...
FDA Grants Alectinib Priority Review for ALK‑Positive Lung Cancer
Genentech announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive,...
FDA Approves Rolapitant for Prevention of Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) approved rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Rolapitant is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
Bristol-Myers Squibb and AbbVie today announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
High Use of Complementary or Alternative Medicines in Older Patients With Cancer
Alternative medicines are widely thought to be at least harmless, and very often helpful, for a wide range of discomforts and illnesses. However, although they’re marketed as “natural,” they often contain active ingredients that can react chemically and biologically with other...
FDA Approves Eltrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
The U.S. Food and Drug Administration approved eltrombopag (Promacta) for the treatment of thrombocytopenia in pediatric patients aged 1 year and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval was...
FDA Grants Regular Approval to Brentuximab Vedotin as Post-Transplant Consolidation Therapy for High-Risk Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced. The...
ASCO Statement: Improving the Evidence Base for Treating Older Adults With Cancer
Older persons are the fastest growing segment of the U.S. population and account for the majority of cancer diagnoses and deaths and the majority of cancer survivors. However, since this population is underrepresented in clinical trials, the evidence base for treating older patients is poor. As...
Study Finds Underinvestment in Long-Term Cancer Research
Pharmaceutical firms underinvest in long-term research to develop new cancer-fighting drugs due to the greater time and cost required to conduct such research, according to a newly published study authored by Massachusetts Institute of Technology (MIT) economists. These findings were published by...
FDA Grants Orphan Drug Designation to Novel Dactinomycin Formulation for Ewing Sarcoma
The FDA has granted Orphan Drug designation to NanoSmart Pharmaceuticals’ novel formulation of dactinomycin for the treatment of Ewing sarcoma, a rare type of childhood bone cancer. The designation was granted on the basis of a plausible hypothesis that the novel formulation, which uses...
FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib...
