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Showing 2851 - 2900FDA Approves Production of Imaging Agent to Detect Prostate Cancer
The FDA approved the production and use of Choline C 11 Injection, a positron-emission tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue ...
FDA Approves First Ultrasound Imaging System for Dense Breast Tissue
The FDA approved somo-v Automated Breast Ultrasound System (ABUS), the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The National Cancer Institute estimates that about 40% ...
FDA Approves New Treatment for Severe Neutropenia
The FDA recently approved Sicor Biotech’s tbo-filgrastim (Neutroval) to reduce the time certain patients receiving chemotherapy experience severe neutropenia. The new drug is a short-acting recombinant granulocyte colony-stimulating factor (G-CSF) agent. It is marketed as Tevagrastim in Europe,...
New Drug Application Submitted for Regorafenib to Treat GIST
Bayer HealthCare and Onyx Pharmaceuticals recently announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for the oral multikinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose...
Novel Device May Eliminate Need for Re-excision after Lumpectomy
A novel device employed during breast surgery reduces the need for re-excision due to positive margins. This lessens patient anxiety, lowers treatment costs, and helps preserve the cosmetic appearance of the breast, according to a large prospective study reported at the 2012 Breast Cancer...
Developments in Hematologic Cancers Include New Considerations in Treating Challenging Leukemias and Multiple Myelomas
Speakers at the National Comprehensive Cancer Network (NCCN) 7th Annual Congress on Hematologic Malignancies reviewed the current standard of care for various hematologic cancers and explored new concepts in treatment. Below are highlights from presentations on chronic myelogenous leukemia (CML),...
Regorafenib Approved for Advanced Colorectal Cancer
The FDA recently approved regorafenib (Stivarga) to treat patients with metastatic colorectal cancer that has progressed after treatment. Regorafenib is a multikinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that ...
Despite Progress, Chemotherapy Drug Shortages Still Vex the Oncology Community
During the first week of November 2011, President Obama signed an Executive Order directing the FDA to take steps to help resolve the drug shortages that were affecting patient care across the country. The oncology community was hit especially hard; many of the drug shortfalls were generic...
A Series of Medical Missteps
Since the beginning of my symptoms—occasional pain on the upper left side of my abdomen, accompanied at times by nausea—which started nearly 20 years ago, my condition, pancreatic neuroendocrine tumor, either remained undetected or was completely misdiagnosed until just recently. A series of...
Novel Drug Combinations Present New Hope for Effective Treatments in Multiple Myeloma
Developing early-phase clinical trials that incorporate combinations of novel agents targeting different pathways in the hematologic cancer multiple myeloma is a leading focus of the work of Sagar Lonial, MD, Professor of Hematology and Vice Chair of Clinical Affairs in the Department of Hematology ...
AACR’s Cancer Progress Report 2012 Highlights Advances, Challenges, Opportunities
The American Association for Cancer Research (AACR) recently released its Cancer Progress Report for 2012,1 providing a snapshot of the major advances in cancer research, and highlighting the great need for continued funding for the field. “It is a new day for cancer research and cancer patients,” ...
Role of Crizotinib in Previously Treated ALK-positive Advanced NSCLC
In yet another success story for personalized medicine, a targeted therapy extended survival in patients whose cancers expressed the target. Crizotinib (Xalkori), the first-in-class ALK inhibitor, extended progression-free survival and improved response rates compared with single-agent chemotherapy ...
Will mTOR Inhibitors Change the Treatment of Endocrine-sensitive HER2-negative Breast Cancer?
For the treatment of endocrine-sensitive metastatic breast cancer, the combination of an mTOR inhibitor and an endocrine agent represents a promising new option. At the 2012 Breast Cancer Symposium, the 18-month update of BOLERO-2, which tested therapy with everolimus (Afinitor) plus exemestane,...
Nab-paclitaxel Approved in First-line Metastatic NSCLC
The FDA has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who are not candidates for ...
Novel Mechlorethamine Gel Considered Safe and Effective for Treatment of Mycosis Fungoides
A novel mechlorethamine, 0.02%, gel produced comparable or higher response rates (depending on the measurement used) than did mechlorethamine, 0.02%, compounded ointment, in a randomized controlled, multicenter study among 260 patients with stage IA to IIA mycosis fungoides, the most common form of ...
CyberKnife M6 Series Gets FDA 510(k) Clearance
Accuray Incorporated has announced that the company received 510(k) clearance from the FDA for its new CyberKnife M6 Series. The CyberKnife M6 Series features expanded clinical capabilities and reduced treatment times. The new CyberKnife M6 FIM and FM Systems, featuring the InCise Multileaf...
Rituximab Infusion Approved for NHL
The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1. Patients with clinically significant cardiovascular disease and high...
FDA Approves New Use of Pemetrexed in the Maintenance Setting for NSCLC
The FDA has expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (Alimta) for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non–small cell lung cancer (NSCLC) followed by pemetrexed maintenance in...
FDA Approves Noninvasive Radiation Therapy to Treat Pain from Bone Metastases
InSightec Ltd announced that the FDA has approved ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate since it was approved in 2004 as ...
New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
AVEO Oncology and Astellas Pharma, Inc, recently announced that AVEO has submitted a New Drug Application (NDA) to the FDA for tivozanib, in patients with advanced renal cell carcinoma (RCC). Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor...
FDA Approves Omacetaxine for Chronic Myeloid Leukemia
The FDA has approved omacetaxine mepesuccinate (Synribo) to treat adults with chronic myelogenous leukemia (CML) whose cancer has progressed after treatment with at least two tyrosine kinase inhibitors. Omacetaxine is injected subcutaneously twice daily for 14 consecutive days over a 28-day cycle...
Updated Results from T-DM1 and Regorafenib Trials, plus Other Highlights from ESMO 2012
The 35th European Society for Medical Oncology (ESMO) Congress in Vienna broke all records for attendance, with about 16,000 attendees from all over the world. Some sessions were standing room only, including the Presidential Symposia, the ESMO-ASCO Joint Symposium on genomics in breast cancer, and ...
Managing Treatment Failure in Chronic Myeloid Leukemia
As John Goldman, DM, FRCP, FRCPath, FMedSci, discussed earlier, a substantial minority of patients with chronic myeloid leukemia (CML) experience treatment failure. Jorge Cortes, MD, of The University of Texas MD Anderson Cancer Center, introduced this session with two patient cases to illustrate...
Introduction
This supplement to The ASCO Post highlights the proceedings of a satellite symposium that was presented as a case-based roundtable discussion titled, Monitoring, Treatment Resistance, and Treatment Failure in Chronic Myeloid Leukemia: Breaking Barriers to Improved Outcomes and Looking Forward to a...
MSKCC’s Decision Not to Purchase New Cancer Drug Sparks Editorial and Unprecedented Actions
“At Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer: we are not going to give a phenomenally expensive new cancer drug to our patients.” That was the opening sentence of a New York Times op-ed piece written by three physicians from Memorial...
Updates on Ruxolitinib from ASCO and ASH 2012, including Long-term Survival Data
Ruxolitinib (Jakafi), a novel, oral JAK1 and JAK2 inhibitor, was approved by the FDA on November 16, 2011 for patients with intermediate- or high-risk myelofibrosis. The approval was based on its efficacy in reducing spleen size and improving disease-related burdensome symptoms. In the brief In the ...
Androgen-deprivation Therapy plus Radiation Proven as Standard of Care for High-risk Prostate Cancer
A combined-modality approach of androgen-deprivation therapy plus radiation therapy achieves a substantial survival benefit over androgen-deprivation therapy alone in patients with locally advanced prostate cancer according to final analysis of an intergroup randomized phase III study conducted by...
The Ethics of Rationing Cancer Care
Should cost be a consideration when deciding on treatment for patients with cancer, and if so, what kind of ethical dilemma does that pose for oncologists? With U.S. spending on oncology drugs expected to climb more than 20% annually over the next decade—reaching $173 billion by 2020, according to...
Clinical Cancer Advances 2012: ASCO’s Annual Report on Progress Against Cancer
Clinical research is continuously delivering new treatments that lengthen and improve the lives of patients with cancer. The abundance of advances reported in the past year illustrates our steady progress in cancer treatment and care. Clinical Cancer Advances 2012: ASCO’s Annual Report on Progress...
2012 In Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2012. Cabozantinib (Cometriq) for the treatment of progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine...
SIDEBAR: REPORT ADVERSE EVENTS
Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mailing the postage-paid...
IMA901 Granted Orphan Drug Designation by FDA
immatics biotechnologies GmbH announced that the cancer vaccine IMA901 has been granted orphan drug designation from the FDA for the treatment of renal cell carcinoma (RCC) in HLA-A*02 positive patients. The FDA grants orphan drug designation to novel drugs aimed at treating rare diseases or...
Supplemental New Drug Application Submitted for Erlotinib as a First-line Therapy in Genetically Distinct NSCLC
Astellas Pharma US, Inc, announced it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for erlotinib (Tarceva) tablets for first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth...
Surefire Medical Receives FDA Clearance for Angiographic Catheters
Surefire Medical, Inc, announced that the company has received 510(k) FDA clearance to market its line of Surefire Angiographic Catheters. Surefire Medical will launch these products in the United States later this year. Surefire’s Angiographic Catheter line is designed to provide interventional...
FDA Grants Fast Track Designation to Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer
Nektar Therapeutics announced that the FDA has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC)....
Cabozantinib Approved for Treatment of Progressive Metastatic Medullary Thyroid Cancer
The FDA recently approved cabozantinib (Cometriq), for the treatment of patients with progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2. The approval was based on the...
Green Tea
The use of dietary supplements by cancer patients has risen significantly over the past 2 decades 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 the...
Physician-Scientist Judah Folkman, MD, Faced Years of Skepticism Before His Theory of Angiogenesis Was Proven
That Moses Judah Folkman would buck tradition, breaking his family’s long line of rabbinical succession and pursuing a career in science and medicine instead, was evident from the time he was a young child. Born in Cleveland on February 24, 1933, the first child of Rabbi Jerome and Bessie Folkman,...
ASCO Report Encourages Further Discussion to Improve REMS Development, Communication
The oncology community—including providers, patients, and industry—and the FDA should continue to work together to improve the agency’s Risk Evaluation and Mitigation Strategies (REMS) program, according to the report of the ASCO REMS Working Group published online by the Journal of Oncology...
Community Research Forum Addresses Conundrums Common to Community Practices that Conduct Research
It is every research site’s biggest concern. The National Cancer Institute (NCI), the FDA, or drug company sponsors could arrive at any time to comb through a site’s documents related to a specific trial. It’s called an audit, and it’s common. And yet, not all sites that conduct research have...
FDA Expands Abiraterone’s Use for Late-stage Prostate Cancer
In December, the FDA approved an expanded indication for abiraterone acetate (Zytiga) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Trial Design The approval was based on a trial randomly assigning patients with metastatic...
Elekta Receives FDA 510(k) Clearance for Clarity 4D Monitoring
Elekta has received 510(k) clearance from the FDA for its Clarity 4D Monitoring software, enabling U.S. medical centers to implement a new way of reducing the uncertainty caused by prostate motion during radiation treatment. Physicians will be able to monitor the motion of the prostate and...
New Drug Application Submitted for Radium-223 for the Treatment of Castration-resistant Prostate Cancer with Bone Metastases
Bayer HealthCare announced that the company has submitted a New Drug Application to the FDA seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of patients with castration-resistant prostate cancer with bone metastases. “If approved, radium-223...
Faster Rituximab Infusion for Previously Untreated Follicular Non-Hodgkin and Diffuse Large B-cell Lymphomas
On October 19, 2012, FDA approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with previously untreated follicular non-Hodgkin or diffuse large B-cell lymphoma who do not experience a grade 3 or 4 infusion-related reaction during cycle 1.1 Patients with clinically...
Omacetaxine for Chronic or Accelerated Phase CML Patients with Resistance/Intolerance to Tyrosine Kinase Inhibitors
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. Indication On October 26, 2012, the FDA granted accelerated...
Fixed-dose Apixaban Reduces Risk of Recurrent Venous Thromboembolism
Venous thromboembolism is a frequent problem in cancer patients, and approximately 20% of all patients who develop the disease have a recurrence. Extending treatment with two fixed doses of the investigational agent apixaban, a factor Xa inhibitor without laboratory monitoring, may provide a...
Overall Survival Benefit Achieved with Pomalidomide in Advanced Myeloma
Support for the oral immunomodulatory agent pomalidomide for multiple myeloma took a step forward when the phase III MM-003 trial showed a survival advantage in patients with advanced disease, in addition to a doubling in progression-free survival, when pomalidomide was given with low-dose...
FDA Approves Ponatinib to Treat CML and Philadelphia Chromosome–positive ALL
In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive...
Pivotal Trial Shows Robust Activity of Ponatinib in Some Heavily Pretreated Leukemias
The pivotal phase II Ponatinib Ph+ ALL and CML Evaluation (PACE trial) found that 1 year of treatment with the novel investigational drug ponatinib achieved robust activity in heavily pretreated patients with chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic...
SIDEBAR: REPORT ADVERSE EVENTS
Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mailing the postage-paid...
