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Showing 951 - 1000New Breast Biopsy System with Vacuum Technology Approved
Devicor Medical Products, Inc, announced that it has received 510(k) clearance from the FDA for the Mammotome elite Biopsy System, a tetherless single-insertion, multiple-sample, vacuum-assisted biopsy device featuring proprietary vacuum technology. Devicor also announced the commercial launch of...
What You Need to Know About Glucarpidase Injection for Toxic Methotrexate Levels in Renal Impairment
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 In January 2012, glucarpidase injection (Voraxaze) was...
Newest Indication for Rituximab as Maintenance Treatment in Non‑Hodgkin Lymphoma
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 The CD20-directed monoclonal antibody rituximab...
Aflibercept Granted Priority Review for Metastatic Colorectal Cancer
Sanofi and Regeneron Pharmaceuticals, Inc, recently announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent aflibercept (Zaltrap) concentrate for solution for infusion in combination with irinotecan/fluoropyrimidine–based...
International Photodynamic Medicine Symposium: Shedding New Light on an Old Therapy
This past May, a collaborative think tank of researchers was convened at The Ohio State University, Columbus, to share their expertise in a somewhat older treatment that is reemerging on many fronts: photodynamic therapy. Participants from the United States, Great Britain, and Japan took part in...
Decoding the Genetic Blueprint of Cancer Cells: Findings in Multiple Myeloma and Breast Cancer
Advances in next-generation DNA sequencing technologies are allowing scientists to decipher the whole genome or whole exome (ie, the coding region of the genome) of cancer specimens more quickly and inexpensively than ever before. And the results are revealing genes that had not previously been...
Multicenter Phase II Trial Supporting Approval of Brentuximab Vedotin in Anaplastic Large-cell Lymphoma
Systemic anaplastic large-cell lymphoma (ALCL) is an aggressive T-cell lymphoma subtype characterized by uniform expression of CD30. Apart from low- to intermediate-risk patients with ALK-positive disease, patients with ALCL have a poor prognosis when treated with conventional, anthracycline-based...
Single Nucleotide Polymorphisms Predict Severe Toxicity of Adjuvant Therapy in Colorectal Cancer
Oxaliplatin/fluoropyrimidine–based adjuvant therapy is of benefit in patients with resected stage II/III colon cancer, but the ability to predict risk of toxicity could improve care by permitting individualization of treatment. Ana Custodio, MD, and colleagues from GEMCAD (Grupo Español...
Blood Test to Improve Prostate Cancer Detection
Beckman Coulter, Inc, recently announced Premarket Approval from the FDA for the Prostate Health Index, a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range and has...
Proton Therapy System Granted 510(k) Clearance
Mevion Medical Systems, Inc, announced that it has received FDA 510(k) clearance for its Mevion S250 Proton Therapy System. According to Mevion, the new system delivers precise, noninvasive treatment comparable to that available with larger, more complex proton therapy systems but with higher...
SIDEBAR: Key Findings
When asked to comment on implications of this study, lead author Frank A. Greco, MD, remarked, “The use of this gene-expression profile assay (CancerTYPE ID, bioTheranostics, Inc) on the biopsy material of patients with carcinoma of unknown primary provides a single tissue of origin diagnosis in...
Gene Profiling–guided Therapy May Improve Survival in Patients with Carcinoma of Unknown Primary
Molecular gene-expression profiling is an emerging technique to determine tissue of origin in patients with carcinoma of unknown primary, although the value of predictions from such profiling in improving treatment outcomes is unclear. In a prospective trial using tumor profiling results to direct...
Conquer Cancer Foundation Honors Oncology Professionals forHigh-quality Research in Breast Cancer
The Conquer Cancer Foundation of ASCO recently announced the recipients of its 2012 Breast Cancer Symposium Merit Awards, which recognize leading oncology professionals for their work in the area of breast cancer research. This year, the Foundation honors 16 individuals for their research in the...
Pertuzumab: New Drug for HER2-positive 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 In June 2012, pertuzumab (Perjeta) was approved for use...
Data Liquidity Coalition Takes Shape
A coalition to promote and implement data sharing in cancer by facilitating data ‘liquidity,’ first proposed in February at an Institute of Medicine (IOM) workshop, is taking shape with the formation of a steering committee and action plans that include a demonstration project. For several years,...
Understanding and Managing Pseudoprogression in Glioblastoma Patients
Pearls in Neuro-oncology is guest edited by Tracy Batchelor, MD, Director, Division of Neuro-Oncology, Massachusetts General Hospital Cancer Center, and Professor of Neurology, Harvard Medical School, Boston. The series is intended to provide the practicing oncologist with guidance in managing...
Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...
Supportive Care Research Runs the Gamut from Genetic Markers of Treatment Side Effects to Neuropathic Pain Therapies
Attendees from around the world gathered for the Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium on Supportive Care in Cancer, held June 28–30 in New York. Below are highlights from the meeting, representing...
Carfilzomib: New Drug with Accelerated Approval for 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 In July 2012, carfilzomib (Kyprolis) was granted...
Ziv-aflibercept with FOLFIRI in Metastatic Colorectal Cancer
In August 2012, the antiangiogenic agent ziv-aflibercept (Zaltrap) was approved for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer resistant to or progressing after an oxaliplatin-containing regimen.1,2 Approval was based on...
NDA for Chemosaturation System to Treat Melanoma in the Liver
Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to...
Paclitaxel Poliglumex Gets Orphan Drug Designation for Glioblastoma Multiforme
Cell Therapeutics, Inc, recently announced that paclitaxel poliglumex (OPAXIO) has been granted orphan drug designation by the FDA for the treatment of glioblastoma multiforme. Orphan designation was granted based on preliminary activity seen from phase II results of paclitaxel poliglumex when...
Enzalutamide for Metastatic Castrate-resistant Prostate 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 In August 31, enzalutamide (Xtandi) was approved for the ...
Hormonal Therapy with Enzalutamide Increases Survival in Castrate-resistant Prostate Cancer after Chemotherapy
The androgen receptor–signaling inhibitor enzalutamide (Xtandi) is reported to differ from conventional antiandrogen agents in that it inhibits androgen receptor nuclear translocation, DNA binding, and coactivator recruitment, has a greater affinity for the androgen receptor, and induces tumor...
Conquer Cancer Foundation Honors Oncology Professionals for High-quality Research in Breast Cancer
More than 15 leading young oncology professionals were honored this year by the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) with 2012 Breast Cancer Symposium Merit Awards for their work in breast cancer research. These trainees submitted high-quality abstracts...
Bosutinib in Chronic Myelogenous Leukemia Patients with Resistance or Intolerance of Prior 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. Indication In September 4, 2012, bosutinib (Bosulif) was approved...
21-gene Recurrence Score Predicts Outcomes of Node-positive, ER-positive Patients after Adjuvant Chemoendocrine Therapy
The 21-gene recurrence score (obtained with Oncotype DX) can help identify patients with estrogen receptor (ER)-positive, node-positive breast cancer who do not respond well to adjuvant chemoendocrine therapy, according to a retrospective analysis of the National Surgical Adjuvant Breast and Bowel...
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...
Vismodegib: Novel Agent for Treating Advanced Basal Cell Carcinoma
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 In January 2012, vismodegib (Erivedge) was approved...
Conquer Cancer Foundation of ASCO Honors Researchers for Work in Measuring and Improving Quality of Cancer Care
The Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) recently announced the first-ever recipients of its Quality Care Symposium Merit Awards. This year’s recipients will be recognized at ASCO’s inaugural Quality Care Symposium, taking place November 30 and December 1 in ...
IOM Elects New Members, Foreign Associates
The Institute of Medicine (IOM) recently announced the names of 70 new members and 10 foreign associates during its 42nd Annual Meeting, in Washington, DC. Election to the IOM is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have...
Regorafenib, Multikinase Inhibitor, for Previously Treated Metastatic Colorectal 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 September 27, 2012, regorafenib (Stivarga) was...
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...
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...
CE Activity Instructions
*Corresponding author, MediCom Worldwide, Inc, 101 Washington Street, Morrisville, PA 19067, e-mail: gtombler@medicaled.com Activity Release Date: November 15, 2012Period of Validity: November 15, 2013 Program Overview This activity presents highlights from a satellite symposium held in...
American Society of Hematology Launches ASH Foundation
The American Society of Hematology (ASH) has announced the creation of the ASH Foundation dedicated to curing blood diseases. The new foundation will complement and build on the work of the Society by harnessing the generosity of donors to expand the reach of successful ASH programs and develop new ...
Liposomal Vincristine for Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
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 In August 2012, vinCRIStine sulfate LIPOSOME injection...
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...
Molecular Breast Imaging an Option for Early Detection in High-risk Women
Molecular breast imaging, also known as breast-specific gamma imaging, was a key topic of discussion at the Radiological Society of North America (RSNA) Annual Meeting, held recently in Chicago. Molecular breast imaging can detect breast cancer missed by mammography, according to clinical data...
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...
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...
ACS Releases Lung Cancer Screening Guidelines
As reported online in CA: A Cancer Journal for Clinicians,1 based on results from the National Lung Screening Trial (NLST) sponsored by the National Cancer Institute (NCI), the American Cancer Society (ACS) has released lung cancer screening guidelines recommending that select clinicians should...
Ponatinib in Chronic Myeloid Leukemia and Philadelphia Chromosome–positive Acute Lymphoblastic Leukemia
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 December 14, 2012, ponatinib (Iclusig) was granted...
Gene in Eye Melanomas Linked to Good Prognosis
Melanomas that develop in the eye often are fatal. Now, researchers at Washington University School of Medicine and the Siteman Cancer Center, St. Louis, Missouri, report they have identified a mutated gene in melanoma tumors of the eye that appears to predict a good outcome. The research was...
Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer and No Prior Chemotherapy
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 December 10, 2012, abiraterone acetate (Zytiga)...
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...
