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Showing 901 - 950Important Briefs from the 2011 Breast Cancer Symposium
The 2011 Breast Cancer Symposium was recently held in San Francisco, bringing together a multidisciplinary group of specialists and sponsored by ASCO, the American Society for Radiation Oncology, the Society of Surgical Oncology, the American Society of Breast Disease, the American Society of...
Gel for Blood Vessel Surgery Approved
The FDA has approved LeGoo (PluroMed Inc, Woburn, Mass), a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops. LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels....
Fewer Rectal Side Effects with IMRT than with 3D-CRT for Prostate Cancer
The use of intensity-modulated radiation therapy (IMRT) is associated with fewer acute and late toxic effects than is three-dimensional conformal radiation therapy (3D-CRT) in men with localized prostate cancer, according to preliminary analysis of the Radiation Therapy Oncology Group (RTOG) 0126...
NCCN Meeting Addresses Issues in Hematologic Malignancies
The National Comprehensive Cancer Network (NCCN) 6th Annual Congress on Hematologic Malignancies, held recently in New York, included reviews of the management of hematologic diseases as well as discussions of outstanding issues in the field. The following is a synopsis of some of the important...
New Drug Approved to Treat Acute Lymphoblastic Leukemia
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed...
Update on Novel Treatments for Peripheral T-cell Lymphoma
At the recent Pan-Pacific Lymphoma Conference in Kauai, Hawaii, Julie M. Vose, MD, from the University of Nebraska Medical Center, Omaha, discussed novel treatments for peripheral T-cell lymphoma (PTCL). PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin...
What You Should Know about Denosumab (Prolia) for Increasing Bone Mass during Breast and Prostate Cancer Therapies
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. Indications In September 2011, the monoclonal antibody RANKL...
Investigational New Drug Application Filed for ONT-10
Oncothyreon Inc announced the filing of an Investigational New Drug (IND) application with the FDA for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA’s review of the IND, Oncothyreon expects to initiate a phase I trial. ONT-10 is a therapeutic vaccine...
Abiraterone: New Drug in the Treatment of Metastatic Castration-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 Abiraterone acetate (Zytiga) (an oral agent that...
A Second Chance for Gemtuzumab in Acute Myeloid Leukemia
Gemtuzumab ozogamicin (Mylotarg) may have a second chance for regulatory acceptance, as studies presented at ASH 2011 demonstrated that gemtuzumab can be safely and effectively given by adjusting the dosing and treatment schedule. Gemtuzumab ozogamicin was approved for the treatment of acute...
Significant Differences in Genetic Characteristics of Primary Colorectal Cancer and Hepatic Metastases
Vermaat and colleagues from the University Medical Center Utrecht, Hubrecht Institute, Utrecht, The Netherlands, and Hoffman-La-Roche Inc./Genentech, Nutley, New Jersey, recently showed that there was significant genetic variation between individual primary colorectal cancer tumors and their...
Ki-67 Image Analysis and Digital Read Applications Cleared
Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image...
GU Symposium 2016: Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer
New analyses from a phase III clinical trial of patients with previously treated advanced kidney cancer demonstrated that patients of all risk levels experience more benefit from cabozantinib (Cometriq) than from the current standard of care, everolimus (Afinitor). The greater activity of...
Liposomal Vincristine Receives Positive Vote from ODAC
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
Erwinia chrysanthemi Asparaginase for Acute Lymphoblastic Leukemia in Patients with Hypersensitivity to E coli–derived Asparaginase
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 Erwinia chrysanthemi asparaginase (Erwinaze) was...
FDA Approves New Silicone Gel–filled Breast Implant
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
2012 Breast Cancer Symposium to Expand Tumor Board Session, Add ‘Meet the Professors’ Session
The days of attending the Breast Cancer Symposium, just quietly listening to useful lectures, and then going home are over. In recent years, the meeting’s sponsors and planners have worked to make the 3-day gathering far more interactive and as intimate as a meeting with 1,500 attendees can be....
FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344
Marshall Edwards, Inc, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced that it has received approval from the FDA of its Investigational New Drug (IND) application for ME-344, the Company’s lead mitochondrial inhibitor. The...
Clinical Findings and Consequences of Distributing Counterfeit Drugs for Hematology and Oncology
As introduced in our report on page 1 of this issue, counterfeit pharmaceuticals are an increasingly important safety concern, and three of the most prominent drug-counterfeiting episodes in recent years have involved hematology/oncology products. Counterfeit Erythropoietin Helen B., a 61-year-old...
ColoPrint Gene Assay Can Guide Treatment Decisions in Stage II Colon Cancer
ColoPrint, an 18-gene expression profile assay for patients with early-stage colon cancer, accurately stratifies patients by recurrence risk and identifies a subset who can be adequately treated by surgery alone, investigators reported at the 2012 Gastrointestinal Cancers Symposium.1 According to...
ASCO Continues to Support Oncologists in Electronic Health Records Adoption at 2012 Annual Meeting
As part of its ongoing effort to support oncology practices in adopting Electronic Health Records (EHR) to improve their quality of care, ASCO is holding its sixth annual EHR Vendor Lab, from June 2-4 at the 2012 ASCO Annual Meeting in Chicago. This resource gives attendees the opportunity to test...
Novel Initiative to Address Oncology Drug Crisis
Much has been written about the oncology drug shortage crisis in the United States. In the spirit of being part of the solution to that problem, a group of oncologists has formed the Citizen’s Oncology Foundation (COF). The goal of the start-up not-for-profit association is two-pronged: to find...
Inhibition of SFRP2 Found to Inhibit Growth of Triple-negative Breast Tumors
Secreted frizzled related protein 2 (SFRP2), a protein that modulates the Wnt signaling pathway and is involved in embryonic development, has been thought to exert a tumor-suppressive effect via inhibition of β-catenin activation. However, researchers at the University of North Carolina at Chapel...
New 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...
