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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...

skin 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 ...

hematologic malignancies
leukemia

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...

lung cancer

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...

breast cancer

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...

lymphoma

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...

leukemia

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...

thyroid cancer

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...

myelodysplastic syndromes

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...

breast cancer

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...

lung cancer

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...

leukemia

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...

solid tumors

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...

prostate cancer

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)...

leukemia
lymphoma
multiple myeloma

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...

colorectal cancer

Bevacizumab plus Chemotherapy after Progression of Metastatic Colorectal Cancer on First-line Therapy Including Bevacizumab 

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 January 23, 2013, bevacizumab (Avastin) was approved...

colorectal cancer

A New Donor Shines with Conquer Cancer Foundation

To support all of our valuable programs for patients and physicians, the Conquer Cancer Foundation of the American Society of Clinical Oncology partners with organizations of every size and scale, and every partnership has a lasting impact. Recently, the Foundation began working with a new...

Expert Point of View: Laura van't Veer, PhD

Laura van’t Veer, PhD, Director of the Specialized Programs of Research Excellence (SPORE) of the University of California, San Francisco, commented on the meta-analysis. She said the study confirms that a pathologic complete response in the neoadjuvant setting is generally meaningful as it clearly ...

breast cancer

21-gene Recurrence Score Does Not Predict Paclitaxel Benefit  

The 21-gene recurrence score significantly predicted the risk of recurrence and death in node-positive, estrogen receptor–positive patients treated with adjuvant chemoendocrine therapy, but it did not predict benefit from the addition of paclitaxel to the regimen in a subset of patients from the...

Expert Point of View: Laura J. van ’t Veer, PhD and Andrew Seidman, MD

Laura J. van ’t Veer, PhD, Leader of the Breast Oncology Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, commented on the findings. “These investigators confirm in a robust meta-analysis that neoadjuvant chemotherapy response is different...

issues in oncology

ASCO Congratulates QOPI-Certified Practices

QCP™: Recognizing Excellence The QOPI® Certification Program (QCP™) recognizes medical oncology and hematology/oncology practices that are committed to delivering the highest quality of cancer care. QCP evaluates an individual practice’s performance in areas that affect patient care and safety. The ...

hematologic malignancies

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...

kidney cancer

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...

American Association for Cancer Research Inaugurates the First Class of Fellows of the AACR Academy

The American Association for Cancer Research (AACR) inaugurated the first class of Fellows of the AACR Academy at the association’s annual meeting held this month in Washington, DC. The AACR Academy has been created to recognize and honor distinguished scientists whose major scientific...

breast cancer

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...

breast cancer
skin cancer

FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers

The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Tilmanocept is an imaging drug that...

breast cancer
issues in oncology

Mammography Screening and DCIS

I would like to suggest that ASCO take a proactive approach to the treatment of ductal carcinoma in situ (DCIS) and the problem it presents to the oncology community. There has been and continues to be heated debate around the value of mammography screening because of “overdiagnosis,” which in my...

leukemia

Drug Approvals in Acute Myeloid Leukemia: Can We Do Better? 

Forty years ago, President Richard Nixon announced a “war on cancer.” Some of that war’s first battles were won in the field of acute myeloid leukemia (AML) with two agents, cytarabine and daunorubicin, receiving U.S. Food and Drug Administration (FDA) approval based on their ability to produce...

issues in oncology
symptom management

FDA Approves Antiemetic Drug for New Line of Prefilled Generic Injectables

BD Rx Inc, announced that the FDA has approved metoclopramide hydrochloride, an injectable antiemetic, as the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables. BD Simplist prefilled injectables are designed to help improve...

leukemia

Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA

Pharmacyclics, Inc, announced that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm of...

issues in oncology

Making Prevention and Early Detection of Cancer a Priority 

Conquering cancer has been the goal of Bert Vogelstein, MD, since he was a teenager in Baltimore. For more than 3 decades, Dr. Vogelstein, Co-Director of the Ludwig Center for Cancer Genetics and Therapeutics and Investigator of the Howard Hughes Medical Institute at Johns Hopkins Medical...

solid tumors
prostate cancer

Phase II Trial Targeting Genetic Anomaly in Castration-resistant Metastatic Prostate Cancer Underway

A new clinical trial is testing whether targeting treatments to a genetic anomaly can lead to better treatments for castration-resistant metastatic prostate cancer. The trial, led by investigators at the University of Michigan Comprehensive Cancer Center, is being conducted at 11 sites throughout...

solid tumors
kidney cancer

No Difference in Overall Survival with Axitinib or Sorafenib in Second-line Treatment for Advanced Renal Cell Carcinoma 

The phase III open-label AXIS trial comparing axitinib (Inlyta) vs sorafenib (Nexavar) as second-line treatment for metastatic renal cell carcinoma showed significantly prolonged independent radiology committee–assessed progression-free survival with axitinib treatment (hazard ratio [HR] = 0.665, P ...

skin cancer

Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation

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 May 29, 2013, trametinib (Mekinist) was approved by...

skin cancer

Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation 

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 May 29, 2013, dabrafenib (Tafinlar) was approved for ...

issues in oncology
legislation

College of American Pathologists Issues Statement on Supreme Court Gene Patent Decision

In a statement released earlier this month, the College of American Pathologists applauded the unanimous Supreme Court decision invalidating the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, calling the decision “a victory for patients and for science.” The College of American...

lung cancer

Erlotinib in First-line Treatment of Metastatic NSCLC with EGFR Exon 19 Deletion or Exon 21 (L858R) Substitution 

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 May 14, 2013, erlotinib (Tarceva) was approved for...

prostate cancer

Radium-223 Dichloride for Castration-resistant Prostate Cancer with Symptomatic Bone Metastases 

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 May 15, 2013, radium Ra 223 dichloride (Xofigo) was...

prostate cancer

Two New Genetic Tests Offer Progress in Personalized Medicine for Newly Diagnosed Prostate Cancer 

At least 12 different genetic tests for prostate cancer are under development. The two tests currently available are Oncotype DX (Genomic Health, Redwood City, California) and Prolaris (Myriad Genetic Laboratories, Salt Lake City). Both tests can identify which low-risk patients are “truly” at low...

issues in oncology
legislation

Supreme Court Rules Human Genes May Not Be Patented 

On June 13, the U.S. Supreme Court ruled unanimously that isolated human genes may not be patented. However, the creation of synthetic forms of DNA, known as complementary DNA (cDNA), is eligible for patent protection. The decision resolves the question brought before the Supreme Court justices in...

issues in oncology

Co-discoverer of DNA Double Helix, James Watson, PhD, Offers a New Theory on Cancer Progression 

Despite his fame as co-discoverer—along with Francis Crick, PhD—of the double-helix structure of deoxyribonucleic acid (DNA) in 1953, that accomplishment is not what James Dewey Watson, PhD, came to talk about during a recent presentation he gave at the World Science Festival in New York. Instead,...

solid tumors

Denosumab in Adults and Skeletally Mature Adolescents with Giant Cell Tumor of Bone 

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 June 13, 2013, denosumab (Xgeva) was approved for the ...

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