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Showing 901 - 950DigniCap Scalp Cooling System Now Available for Women With Breast Cancer at 10 U.S. Cancer Treatment Centers
Dignitana Inc. announced today that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment...
Introduction of New Diagnostic Devices in Oncology: New Is Not Necessarily Better
“New!” “Improved!” “Throw out that old [fill in the blank] and go buy a new [fill in the blank]!” Sound familiar? The key to marketing is to convince customers that they need a product without which they had previously been quite happy. All too often, this strategy is accompanied by a caveat emptor ...
Lauren Streicher, MD, Announced as Medical Director for Northwestern Medicine’s Upcoming Center for Sexual Health
Northwestern Medical Group recently announced that Lauren Streicher, MD, will be joining Northwestern Medicine in Chicago. Dr. Streicher is a clinical leader in gynecology, a published author, and a trusted medical contributor for many local and national media outlets. In her new role, Dr....
Obinutuzumab in Relapsed or Refractory Follicular Lymphoma
On February 26, 2016, obinutuzumab (Gazyva) was approved for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for treatment of patients with follicular lymphoma who have relapsed after or are refractory to a rituximab (Rituxan)-containing regimen.1,2...
Palbociclib Combined With Fulvestrant in Advanced Breast Cancer Progressing After Endocrine Therapy
On February 19, 2016, palbociclib (Ibrance) was approved for use in combination with fulvestrant (Faslodex) for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.1,2 In February 2015, palbociclib in...
Global Perspectives on the Integration of Biosimilars Into Oncology Practice
Dr. Robert Rifkin, Medical Director of Biosimilars at US Oncology Research, moderates a roundtable discussion on Global Perspectives on the Integration of Biosimilars into Oncology Practice, held in conjunction with the 2015 American Society of Hematology Annual Meeting in Orlando, Florida....
Atezolizumab Improves Survival vs Docetaxel in Advanced NSCLC in Relation to Increased PD-L1 Expression
In the phase II POPLAR trial reported in The Lancet, Fehrenbacher et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab improved overall survival vs docetaxel in patients with non–small cell lung cancer (NSCLC) who had progressed on prior platinum-based...
An Increase for the National Institutes of Health Budget
The National Institutes of Health (NIH) received a nearly $2 billion funding increase—the first large increase for the agency in more than 12 years—in the federal omnibus spending bill Congress passed on December 18, 2015. And President Barack Obama signed the bill into law a day later. The 6.6%...
Eribulin Mesylate in Advanced Liposarcoma Previously Treated With an Anthracycline
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. On January 28, 2016, eribulin mesylate (Halaven) was approved for...
First-in-Class Drug ONC201 Shows Potential for Some Blood Cancers
ONC201, an investigational anticancer drug that triggers cell death in various tumor types, may have clinical potential for some blood cancers including mantle cell lymphoma and acute myeloid leukemia (AML), according to a recent clinical study. A research team led by Michael Andreeff, MD, PhD,...
Rolapitant Reduces Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately and Highly Emetogenic Chemotherapy
In three phase III studies reported in The Lancet Oncology, the addition of the neurokinin-1 (NK-1) receptor antagonist rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in the prevention of chemotherapy-induced nausea and ...
Study Finds Enzalutamide Increases Progression-Free Survival vs Bicalutamide in Metastatic Prostate Cancer
Use of the androgen receptor–inhibitor enzalutamide (Xtandi) more than doubled progression-free survival vs the nonsteroidal antiandrogen bicalutamide in patients with metastatic prostate cancer progressing on androgen-deprivation therapy, according to the randomized phase II TERRAIN trial...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
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. On December 11, 2015, alectinib (Alecensa) was granted...
Hospira Foundation Donates $5 Million to the University of Chicago Medicine
The Hospira Foundation has donated $5 million to the University of Chicago Medicine to create the Hospira Foundation Professorship in Oncology. The Hospira Foundation Professor will be a key leader in advancing the University of Chicago Medicine’s cancer research objectives, which include...
Fear’s Many Deleterious Consequences
Bookmark Title: The Fear Cure: Cultivating Courage as Medicine for the Body, Mind, and Soul Author: Lissa Rankin, MD Publisher: Hay House, Inc Publication date: February 23, 2015 Price: $25.99; hardcover, 336 pages Fear is a healthy survival mechanism, a fight-or-flight response designed to put...
Global Perspectives on the Integration of Biosimilars Into Oncology Practice
Dr. Robert Rifkin, Medical Director of Biosimilars at US Oncology Research, moderates a roundtable discussion on Global Perspectives on the Integration of Biosimilars into Oncology Practice, held in conjunction with the 2015 American Society of Hematology Annual Meeting in Orlando, Florida....
NCCN Awards Research Grants to Five Investigators to Study Effectiveness of Enzalutamide in Various Cancers
The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has awarded five grants to investigators to evaluate and define the preclinical and clinical effectiveness of enzalutamide (Xtandi) in mantle cell lymphoma and endometrial, hepatocellular, and prostate cancers. These...
2016 GI Symposium: Irinotecan Liposome Injection in Metastatic Pancreatic Cancer: Updated Results of the Phase III NAPOLI-1 Study
Merrimack Pharmaceuticals, Inc, announced that an updated overall survival analysis of the phase III NAPOLI-1 study of irinotecan liposome injection (Onivyde) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival compared to 5-FU and...
Phase I Trial Shows Injectable Agent Illuminates Cancer During Surgery
Doctors at the Duke University School of Medicine have tested a new injectable agent that causes cancer cells in a tumor to fluoresce, potentially increasing a surgeon’s ability to locate and remove all of a cancerous tumor on the first attempt. The imaging technology was developed through...
New Drug Application Submitted for Vemurafenib in Melanoma
Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has...
Expert Point of View: Sunitinib/Prednisone Improves Progression-free Survival but not Overall Survival in Metastatic Castrate-resistant Prostate Cancer
Philip W. Kantoff, MD, of the Dana-Farber Cancer Institute, emphasized that this was essentially a negative study. “There is no evidence that VEGFR-targeted agents provide a survival benefit for men with advanced prostate cancer,” he indicated. “With shrinking resources and a rapidly improving...
Axitinib Improves Progression-free Survival over Sorafenib in Advanced Renal Cell Carcinoma
A randomized comparative effectiveness phase III trial demonstrated significantly superior efficacy for the tyrosine kinase inhibitor axitinib compared to sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC). These data suggest that axitinib may become a new standard of care for ...
Are Clinical Pathways Inevitable in Oncology’s Future?
Our health-care system is undergoing a gradual but inevitable sea change, shifting from traditional fee-for-service to fee-for-value. A session at this year’s Association of Community Cancer Centers meeting in Washington, DC, shed light on how this trend will reshape incentives and the clinical...
ODAC Recommends Accelerated Approval for Brentuximab
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant...
Tissue of Origin Test Evaluated in Patients with Cancer of Unknown Primary
According to results of a study published in the Journal of Molecular Biomarkers and Diagnosis,1 the recently developed Tissue of Origin Test (Pathwork Diagnostics, Inc) aids in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history,...
Radium-223 Chloride Gets Fast Track Designation
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and...
Important 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...
