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Showing 13551 - 13600FDA Approves Imatinib for Expanded Use in GIST
The FDA has granted imatinib mesylate (Gleevec) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The new approval also highlights an increase in overall patient survival when the drug is taken for 36 months rather than...
ASCO Membership Categories Offer a Place for Everyone
If your work touches those who have cancer, you have a place within ASCO. That’s the message that the organization, during its 48 years, has gotten across in many ways, not the least of which is its membership categories, which have expanded right along with the field of cancer care. “ASCO is...
Ablation of Small Primary Breast Tumors: The Next Step in Local Therapy?
Local treatment of breast cancer is trending toward less invasive procedures that achieve comparable outcomes to standard interventions. What will the next step along this continuum be? According to Michael S. Sabel, MD, a surgical oncologist at the University of Michigan Comprehensive Cancer...
Subcutaneous Bortezomib Approved
The FDA has approved a supplemental new drug application for bortezomib (Velcade), updating the label to include the subcutaneous administration in all indications approved for intravenous administration, ie, multiple myeloma and mantle cell lymphoma after at least one prior therapy. The approval...
FDA Completes Work on Three Drug User Fee Programs
The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of...
Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products
The FDA has approved a new transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy (REMS) access program. The REMS is a single shared system for all transmucosal immediate-release fentanyl products. Among the goals of the REMS access program are to mitigate the risk of...
Glucarpidase Approved to Treat Methotrexate Toxicity
The FDA has approved intravenous glucarpidase (Voraxaze) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Glucarpidase is an enzyme that rapidly reduces methotrexate levels by breaking down the chemotherapy drug to a form that can be eliminated from the...
Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy
The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive...
FDA Approves Vismodegib for Basal Cell Carcinoma
The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic...
Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma
The FDA has approved the kinase inhibitor axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. The approval is based on an international, randomized, open-label trial that enrolled 723 patients: 361 were assigned to receive axitinib at 5 ...
Cost of Care: A Multidisciplinary Responsibility
I read the interview with Dr. Ezekiel Emanuel (The ASCO Post, December 15, 2011) with much interest, as the health-care policy problems that America is currently experiencing have plagued other countries for some time. Despite proactive measures and attempts to amend those situations elsewhere,...
Drug Shortages Hit Oncology Hard: Experts Weigh in on Challenges and Solutions
Periodic drug shortages are an unavoidable reality in our complicated pharmaceutical supply chain; however, over the past several years, drug shortages have expanded to crisis levels, putting vulnerable patients at risk. In 2010, there were 178 drug shortages reported to the FDA, 132 of which were...
Expert Point of View: Maintenance Rituximab vs Retreatment Rituximab in Patients with Low–Tumor-Burden Follicular Lymphoma
The findings of RESORT1 have tremendous implications, both clinically and economically, commented Andrew D. Zelenetz, MD, Chief of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center, New York, in an interview. “The maintenance arm received rituximab [Rituxan] every 3 months...
New Immunomodulatory Drug Produces Impressive Phase II Results in Multiple Myeloma
Data on pomalidomide, the novel oral immunomodulatory drug for multiple myeloma, was a major highlight of the 2011 ASH Annual Meeting, according to Kenneth D. Anderson, MD, of Dana-Farber Cancer Institute, Boston, who called the drug “very, very exciting.” Paul Richardson, MD, also of Dana-Farber...
Expert Point of View: Monoclonal Antibody Promising in Multiple Myeloma
With a wealth of new agents of various classes in the pipeline, “myeloma is going to become a chronic illness, with sustained complete responses achieved in a significant fraction of patients,” according to Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute and Harvard Medical School, ...
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...
Expert Point of View: Post-CHOP Radioimmunotherapy Comparable to Rituximab Given along with CHOP in Previously Untreated Follicular Lymphoma
SWOG S0016, which compared treatment with CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, plus rituximab [Rituxan]) and CHOP-RIT (CHOP plus tositumomab/iodine-131 tositumomab [Bexxar]) in patients with follicular lymphoma, was one of the most important studies at the 2011 ASH...
Expert Point of View: Everolimus plus Exemestane Significantly Prolongs Remission in BOLERO-2
Signaling of mammalian target of rapamycin (mTOR) is required for estrogen-induced breast tumor cell proliferation, and hyperactivation of the mTOR pathway is observed in endocrine-resistant breast cancer cells. Clinically, this makes for a rational one-two punch in endocrine-resistant breast...
Expert Point of View: Bevacizumab Progression-free Survival Benefit Upheld in AVEREL Trial
Modest benefit reported from AVEREL1 triggered comments among trialists about the future of bevacizumab (Avastin) in breast cancer. “Although there’s controversy about the recent revoking of FDA approval of bevacizumab for metastatic breast cancer, I think there is a consensus in our disappointment ...
Special Supplement: Reports from the 34th San Antonio Breast Cancer Symposium and the 53rd American Society of Hematology Annual Meeting
The ASCO Post presents this special supplement with comprehensive coverage of important data from the 34th Annual San Antonio Breast Cancer Symposium and the 53rd American Society of Hematology Annual Meeting. In addition to news about the individual abstracts, experts offer their perspectives on...
Pertuzumab Gets Priority Review for Metastatic Breast Cancer
The FDA has accepted Roche’s Biologics License Application for pertuzumab (Omnitarg) and granted Priority Review. The proposed indication is pertuzumab in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable ...
FDA Issues Draft Guidance on Biosimilar Product Development
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at...
2012 Oncology Meetings
MARCH ACR 5th Annual PET/CT SymposiumMarch 1-4 • Stowe, Vermont For more information: www.acr.org 3rd Asian Breast Cancer CongressMarch 3-4 • Bangalore, India For more information: http://abcconline.net TAT 2012 (International Congress on Targeted AntiCancer Therapies)March 8-10 • Amsterdam, The...
Nearly Identical Survival for Laparoscopy vs Laparatomy in Patients with Stage I/IIA Disease
Building on previously reported results that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay endpoints, the Gynecologic Oncology Group reported small and lower than anticipated potential for increase risk of cancer recurrence with laparoscopy...
Addition of Bevacizumab to Neoadjuvant Chemotherapy Increases Pathologic Complete Response Rate in HER2-negative Disease
Two studies reported in The New England Journal of Medicine showed that the addition of bevacizumab (Avastin) to neoadjuvant chemotherapy significantly increased the pathologic complete response rate in women with HER2-negative breast cancer. In one study, from the German Breast Group, the benefit...
A Patient with Cancer Saw a Need and Left a Living Legacy
It is well documented that the rigors of delivering cancer care can unintentionally supersede valuable doctor-patient communication. Before he died in 1995, Kenneth B. Schwartz, a patient with cancer at Massachusetts General Hospital, recognized this phenomenon and founded the Kenneth B. Schwartz...
Reexcision Rates Following Breast-conservation Surgery Vary Widely
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Reexcision rates for women with...
Similar Morbidity, Higher Costs for Robotic vs Laparoscopic Hysterectomy in Women with Endometrial Cancer
A population-based analysis comparing laparoscopic hysterectomy and robotic hysterectomy for endometrial cancer “found similar morbidity but increased cost compared with laparoscopic hysterectomy,” investigators reported in the Journal of Clinical Oncology.1 After adjusting for patient, surgeon,...
Challenges, Progress, and Future Directions in Head and Neck Cancer
Although head and neck cancer remains a major therapeutic challenge, significant advances have been made over the past few decades. The ASCO Post recently spoke with Marshall R. Posner, MD, Medical Director of the Head and Neck Oncology Program, Mount Sinai Medical Center, New York, about the...
Adding Thalidomide to Chemoradiation Increases Toxicities but Not Survival for Stage III Non–Small Cell Lung Cancer
Adding thalidomide (Thalomid) to the third-generation chemotherapy doublet of paclitaxel and carboplatin and radiation for patients with stage III non–small cell lung cancer (NSCLC) increased toxicities but did not improve survival. These results from the Eastern Cooperative Oncology Group (ECOG)...
Career Development Award Recipient Susan K. Parsons, MD, Supports Next Generation of Researchers
Like all pediatric oncologists, Susan K. Parsons, MD, MRP, knows that when a child is diagnosed with cancer, it happens to the whole family. Siblings must cope with everything from disruption of routine to reduced parental attention, to the often-new possibility of mortality. Parents must navigate...
Expert Point of View: Genomics Projects Plumb Breast Cancer’s Inner Workings
Charles M. Perou, PhD, the May Goldman Shaw Distinguished Professor of Molecular Oncology at the University of North Carolina, Chapel Hill, commented on the research being conducted by The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC). “The TCGA and ICGC efforts...
Important News Briefs: New Data Reported in Gastric, Colorectal, and Hepatocellular Cancers
Findings presented at the 2012 Gastrointestinal Cancers Symposium will impact the future care of patients with these malignancies. The ASCO Post has summarized some of the most newsworthy data in the following briefs. In the phase III GRANITE-1 trial (n = 656), single-agent treatment with...
What Were the Take-home Messages from the 2012 Gastrointestinal Cancers Symposium?
Richard M. Goldberg, MD, of The Ohio State University Medical Center, chaired the steering committee of the 2012 Gastrointestinal Cancers Symposium in San Francisco, which attracted approximately 4,000 registrants who viewed data from some 700 scientific abstracts. The ASCO Post asked Dr. Goldberg...
Lung Cancer Alliance Announces National Framework for Lung Cancer Screening Excellence
The Lung Cancer Alliance (LCA) moved lung cancer screening to a national platform by announcing a Framework for Lung Cancer Screening Excellence, which includes a bill of rights for the at-risk public and guiding principles for lung cancer screening sites. “The science is indisputable: Screening...
A Visionary Call for the ‘Creative Destruction’ of Medicine
According to nationally regarded cardiologist and geneticist Eric Topol, MD, Chief Academic Officer of Scripps Health, the next frontier of the digital revolution can create exponentially better health care. Dr. Topol, who is also Director of the Scripps Translational Science Institute and...
Two Novel Agents Prolong Survival in Advanced Prostate Cancer
Two novel agents with distinct mechanisms of action join ranks of treatments that extend survival for patients with castration-resistant prostate cancer: MDV3100 and radium-223. Both drugs achieved a survival advantage compared with placebo, with relatively benign side-effect profiles, according to ...
2012 Oncology Meetings
MARCH Hematology/Oncology Pharmacy Association 8th Annual Meeting March 21-24 • Orlando, Florida For more information: www.hoparx.org 65th Society of Surgical Oncology Annual Meeting March 21-24 • Orlando, Florida For more information: www.surgonc.org Society of Interventional Radiology 37th...
VEGFR Tyrosine Kinase Inhibitors Linked to Increased Risk of Fatal Adverse Events
A meta-analysis of 10 randomized controlled trials involving 4,679 patients showed that the use of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors was associated with an increased risk of fatal adverse events. “The crude incidence of [fatal adverse events] in patients ...
Survival Advantage of Oxaliplatin Extends to Diverse Group of Patients
The survival advantage conferred by adding oxaliplatin to adjuvant chemotherapy with fluorouracil (5-FU), as previously shown in randomized controlled trials, extends to patients in the general population, including older and minority group patients and those with higher comorbidity. These results, ...
Cost of Cancer Therapy: The Elephant in the Room?
I am distressed by your coverage of innovative therapies, such as dual HER2 blockade (see The ASCO Post, January 1, 2012, and Supplement to February 15, 2012), without mentioning that these therapies will never be cost-effective given the current pricing of the agents involved. If we wish to...
Adolescents and Young Adults with Cancer: A Distinct Population of Patients Who Need to Be Treated Differently
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Cancer among adolescents and young...
Some Patients Using Complementary and Alternative Therapies May Be Receiving ‘Parallel’ Rather Than Integrative Care
Most patients with cancer receiving complementary and alternative medicine do so not as part of integrative care, but rather as “parallel care,” according to Lynda Balneaves, RN, PhD, Associate Professor, University of British Columbia, School of Nursing in Vancouver. Dr. Balneaves is lead...
Research Funding Key to Continued Progress in Cancer Care
American Association for Cancer Research (AACR) President and ASCO member Judy Garber, MD, MPH, recently spoke with The ASCO Post about the findings of AACR’s landmark Cancer Progress Report,1 In addition, she offered her perspective on the current and future state of cancer research. Project...
Expert Point of View: Maintenance with Lenalidomide or Bortezomib Prolongs Remission in Elderly Patients with Multiple Myeloma
David S. Siegel, MD, PhD, of the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey, commented to The ASCO Post that essentially all patients with multiple myeloma could be candidates for maintenance therapy. “But I don’t know that we have established that maintenance...
Researchers Map Potential Genetic Origins, Pathways of Lung Cancer in Never-smokers
Findings from a small study on potential gene mutations and pathway alterations that could lead to lung cancer in never-smokers were presented in a poster at the American Association for Cancer Research–International Association for the Study of Lung Cancer Joint Conference on Molecular Origins of...
FDA Drug Approvals, January–March 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Accelerated approval for this indication was granted in December 2008. Vismodegib (Erivedge) capsules...
First Urine-based Molecular Test to Gauge Need for Repeat Prostate Biopsies
Gen-Probe announced the FDA has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. “Overexpression of the PCA3 gene is highly specific to cancerous prostate...
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...
ODAC Votes against Denosumab to Delay Bone Metastasis in Men with Castration-resistant Prostate Cancer
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it...
