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Showing 2901 - 2950Updates 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...
Cabozantinib in Metastatic Medullary Thyroid Cancer
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 November 29, 2012, cabozantinib (Cometriq) was...
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 syndromes (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 identify...
Cost of Cancer Drugs: What Price for What Benefit?
In 2011, national health-care spending in the United States was about $2.7 trillion, larger than the entire French national budget.1 U.S. national health-care spending is about 17% of the national gross domestic product. Total Medicare expenditures in 2011 were $549 million.2 In the debate about...
Treatment of HER2-positive Disease in 2013
From the initial discovery of the HER2 family of receptors in the mid-1980s to the present, a “wealth of riches” has been uncovered in terms of agents that can target pathways relevant to this aggressive breast cancer type, notes Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials...
ASH Highlights Included New Data in Myeloma, Lymphoma, and Leukemia, plus Studies of Mucositis and Graft-vs-Host Disease
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
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...
We Need Gemtuzumab Available Again to Treat AML
The word “revival” signifies a renewed use or acceptance after a period of inactivity; similarly, the word “resurrection” refers to the concept of an entity coming back to life after death. In the past year, these terms have been used frequently by us (and others) in articles calling for the return ...
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....
The Challenges and Rewards of Neuro-oncology
Despite the extremely difficult clinical challenges posed by brain tumors, mortality rates in this disease have decreased somewhat over the past several decades due, in part, to advances in surgical techniques and therapies. The ASCO Post recently discussed contemporary issues in neuro-oncology...
Outcomes Comparable for Panitumumab and Bevacizumab in Metastatic Colorectal Cancer
In patients with KRAS wild-type metastatic colorectal cancer, outcomes were comparable whether patients received the epidermal growth factor receptor (EGFR) inhibitor panitumumab (Vectibix) or the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (Avastin). This was shown both in the...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide...
City of Hope Names Robert Stone, JD, as New Chief Executive Officer
After 10 years at City of Hope, in Duarte, California, former FDA acting Commissioner Michael A. Friedman, MD, has decided to retire from his position as Chief Executive Officer, and the Board of Directors has selected current President Robert Stone, JD, to assume the dual role of President and...
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...
Evaluating HER2 Status in Esophageal Cancers: FISH vs Immunohistochemistry
In screening patients with esophageal cancers for HER2 status, the relative efficiency of immunohistochemistry (IHC) vs fluorescence in situ hybridization (FISH) has been debated. Researchers from the Mayo Clinic compared the testing strategies and have proposed an algorithm that puts IHC up front, ...
Bendamustine/Rituximab Noninferior to Standard Chemotherapy for Advanced Indolent Non-Hodgkin and Mantle Cell Lymphomas
The combination of bendamustine (Treanda) and rituximab (Rituxan), or BR, was found to be noninferior to commonly used chemotherapy with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) or R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) in...
Pomalidomide 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. Indication On February 8, 2013, the immunomodulatory agent...
Apogenix Receives FDA Orphan Drug Designation for APG101 to Treat Myelodysplastic Syndromes and Initiates Clinical Phase I Study
Apogenix GmbH, a biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced that its lead compound, APG101 (Apocept), has been granted orphan drug designation from the FDA for the treatment of myelodysplastic syndromes (MDS)....
Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from FDA
Janssen Research & Development, LLC, and Pharmacyclics, LLC, announced that the FDA has granted Breakthrough Therapy Designations for the investigational oral agent ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory mantle cell lymphoma who have...
Colorectal Cancer: A Decade of Progress
The 2013 Gastrointestinal Cancers Symposium marked the 10th anniversary of the meeting. Richard M. Goldberg, MD, the Klotz Family Chair in Cancer Research, Professor of Medicine, and James Cancer Hospital Physician-in-Chief at The Ohio State University, looked back over the decade to highlight the...
T-DM1 for HER2-positive Metastatic Breast Cancer Receives FDA Approval
The FDA approved the antibodydrug conjugate 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 was...
Immunoassay Test May Help Identify Early Kidney Cancer
Renal cell carcinoma is the most common form of adult kidney cancer and the third most common urologic malignancy, accounting for about 2% of all malignancies and 2% of cancer-related deaths worldwide. It is also one of the most difficult cancers to detect and treat because it is usually found...
AACR Briefs Congressional Staffers on Importance of Continued Funding for Research
As we all now know, the start of the sequestration prescribed by the Budget Control Act of 2011 was delayed until March 1, 2013, by the American Taxpayer Relief Act of 2012. With Congress unable to strike a deal, the mandatory reductions in Federal spending were triggered on March 1. Those...
Implementing a National Cancer Clinical Trials System for the 21st Century
In March 2011, the National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. That workshop included...
Ado-Trastuzumab Emtansine in Metastatic Breast Cancer
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 February 22, 2013, ado-trastuzumab emtansine...
