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Showing 3701 - 3728FDA Approves Radium-223 Dichloride for Patients with Castration-resistent Prostate Cancer
On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Radium-223 dichloride is an...
FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for erlotinib (Tarceva). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of...
FDA Warns about Potential Medication Errors Resulting from Confusion Regarding Nonproprietary Name for Kadcyla (ado-trastuzumab emtansine)
The U.S. Food and Drug Administration (FDA) is alerting health-care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine, also known as T-DM1 during preapproval clinical trials) in some medication-related electronic systems...
Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and...
Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma
Merck has announced that the U.S. Food and Drug Administration has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that...
Pharmacyclics Completes Enrollment of Phase III Ibrutinib CLL Study and Phase II Ibrutinib MCL Study
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
New Labeling for Reformulated OxyContin to Curb Abuse
The U.S. Food and Drug Administration has approved updated labeling for the reformulated painkiller OxyContin (controlled-release oxycodone hydrochloride). The new labeling will indicate that the drug has physical and chemical properties that make injection or snorting challenging. This new measure ...
Biomarker Analysis Identified Women Most Likely to Benefit from T-DM1
For women with metastatic, HER2-positive breast cancer, the amount of HER2 on their tumor might determine how much they benefit from T-DMI—also now known as ado-trastuzumab emtansine (Kadcyla)—according to data from a subanalysis of the phase III clinical trial that led the FDA to...
Statement by ASCO President Sandra M. Swain, MD, FACP, in Support of the Rally for Medical Research, April 8, 2013
A strong, stable federal investment in cancer research, prevention, and treatment is critical to continue the progress we are making for the more than 1.66 million Americans newly diagnosed with cancer every year. ASCO calls on Congress to renew its commitment to this life-sustaining research. As...
Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced today that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm...
New Minimally Invasive, MRI-guided Laser Treatment for Glioblastoma Found to Be Promising in Study
The NeuroBlate Thermal Therapy System provides a new, safe, and minimally invasive procedure for treating recurrent glioblastoma, according to the first-in-human study of the system. The study, published online today in the Journal of Neurosurgery, was written by lead author Andrew Sloan, MD,...
Ganetespib Demonstrates Potency against ALK-positive Lung Cancer and Overcomes Crizotinib Resistance
A drug that indirectly impairs the function of several cancer-driving proteins, including anaplastic lymphoma kinase (ALK), may be an effective new treatment for patients with ALK-positive non–small cell lung cancer (NSCLC). The drug, ganetespib, may also be effective for treating patients...
New Imaging Agent Enables Better Cancer Detection, More Accurate Staging
Researchers at the University of California, San Diego School of Medicine have shown that a new imaging dye, designed and developed at UC San Diego Moores Cancer Center, is an effective agent in detecting and mapping cancers that have reached the lymph nodes. The radioactive dye technetium Tc-99m...
Cancer Drug Shortages Mean Higher Costs and Greater Risk for Patients
A national survey of health professionals showed that drug shortages are taking a heavy toll on cancer patients, forcing treatment changes and delays that for some patients meant worse outcomes, more therapy-related complications, and higher costs. St. Jude Children’s Research Hospital...
Moffitt Cancer Center Researchers Study Use of Dasatinib for Patients with High-risk MDS
Researchers at Moffitt Cancer Center have completed a phase II clinical trial to determine the safety and efficacy of dasatinib (Sprycel) for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia, or acute myeloid leukemia resulting from MDS and have failed ...
FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Technetium Tc 99m tilmanocept is an...
IOM Gauges Progress in Goals for Improving the Cancer Clinical Trials System
The National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop in February to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. This was a follow-up meeting to...
Trio of Biomarkers May Help Identify Kidney Cancer in Early Stages
A new immunoassay that tests for the presence of three biomarkers appears to be a valid screening method for the early detection of malignant kidney cancer, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research....
Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System
Royal Philips Electronics today announced that it has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography system that has the capability to enable future single-shot spectral imaging applications. High Breast Density High breast density is a known...
FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors
The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes...
FDA Approves New Treatment for HER2-positive, Metastatic Breast Cancer
The FDA approved ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. “[Ado-trastuzumab emtansine] is trastuzumab...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide, an oral immunomodulatory agent, is intended for patients who have received at least two prior therapies, including lenalidomide...
High-dose Vorinostat Effective at Treating Relapsed Lymphomas, Study Finds
Reporting the results of a phase I clinical trial to test the effectiveness of a new class of drugs to augment standard chemotherapy, a team led by Fred Hutchinson Cancer Research Center scientists found that giving patients high doses of vorinostat (Zolinza) in combination with another round...
FDA Approval of Generic Version of Liposomal Doxorubicin Injection Is Expected to Help Resolve Shortage
The FDA has approved the first generic version of liposomal doxorubicin (Doxil), which is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
Bevacizumab Approved as Combination Therapy for Metastatic Colorectal Cancer after Progression on First-line Bevacizumab Therapy
On January 23, 2013, the FDA approved bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab-containing...
Ezatiostat Gets Orphan Designation for Treatment of Myelodysplastic Syndrome
Telik, Inc, announced that its product candidate, ezatiostat hydrochloride (Telintra), has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). Ezatiostat is an investigational agent in development for the treatment of MDS and idiopathic chronic...
Dune Medical Devices Receives FDA Approval for the MarginProbe System
Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively ...
