Search Results
Your search for ,Fda matches 3728 pages
Showing 2801 - 2850FDA Approves Pertuzumab for HER2-positive Metastatic Breast Cancer
The FDA has approved pertuzumab (Perjeta), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, pertuzumab is combined with...
Too Soon to Know How Circulating Tumor Cells Might Be Used to Guide Treatment of Breast Cancer
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. “A simple blood test.” These were...
Novel Agent Carfilzomib Receives Positive Vote from Oncologic Drugs Advisory Committee for Use in Multiple Myeloma
Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11–0 (with 1 abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome...
SIDEBAR: Expect Questions from Your Patients
Promising results announced at the recent ASCO Annual Meeting from studies with BRAF and MEK inhibitors have made headlines, but only one of these agents—the BRAF inhibitor vemurafenib (Zelboraf)—has been approved by the FDA. The others are still investigational. Patients interested in gaining...
MEK Inhibitor Reduces Progression of BRAF-mutated Melanoma and Might also Benefit Others
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. The MEK inhibitor trametinib...
Cabozantinib Prolongs Progression-free Survival in Advanced Medullary Thyroid Cancer
Cabozantinib prolonged progression-free survival in patients with unresectable, locally advanced, or metastatic medullary thyroid cancer with documented disease progression in the phase III EXAM trial. Based on these results, Exelixis submitted a New Drug Application to the FDA in May 2012. The...
NK Cell Signature Associated with Favorable Prognosis in Breast Cancer
Tumor cell recognition by natural killer (NK) cells is mediated by the interaction of activating and inhibitory NK cell receptors with ligands expressed on the tumor cells. NK cells also express adhesion molecules that facilitate formation of the immune synapse with tumor targets. Maria Libera...
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...
System for Breast Cancer Surgeries Gets Positive Vote
Dune Medical Devices announced that an FDA Advisory Panel voted 10 to 1 in favor of Dune’s MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment. Dune submitted a Premarket Application (PMA) in April 2011 based on ...
Regorafenib in Metastatic Colorectal Cancer
Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose...
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...
FDA Approves Cetuximab plus FOLFIRI/Therascreen in Colorectal Cancer
The FDA has granted approval to cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation–negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. ...
After a Decade of Decline in Smoking Rates, Progress Has Stalled
Approximately 20% of all Americans smoke, and 443,000 of them will die each year as a result. Tobacco use is the leading cause of preventable death in the United States and the greatest behavioral determinant of morbidity and mortality (6%–10% of U.S. health-care costs). Nearly 30% of all cancer...
PACE Trial Update: Ponatinib Produces High Response Rates in CML
The third-generation tyrosine kinase inhibitor ponatinib showed robust efficacy in the 10-month follow-up of the phase II PACE trial (Ponatinib Ph+ALL and CML Evaluation), which is evaluating ponatinib in treatment-refractory chronic myeloid leukemia (CML)1 At the 2012 ASCO Annual Meeting, Jorge E. ...
First-line Afatinib Superior to Standard Chemotherapy in Advanced EGFR-mutated Non–Small Cell Lung Cancer
First-line therapy with the investigational oral agent afatinib improved progression-free survival compared with standard chemotherapy (pemetrexed (Alimta)/cisplatin) in patients with advanced non–small cell lung cancer (NSCLC) harboring an EGFR mutation. Afatinib improved progression-free survival ...
Expert Point of View: Landscape for Treatment of Metastatic Melanoma Is Expanding
At an Annual Meeting press conference, ASCO spokesperson Sylvia Adams, MD, said, “BREAK-3 confirms that BRAF targeting is effective in metastatic melanoma. The tumor shrinkage seen with dabrafenib is similar to results observed for the FDA-approved drug vemurafenib, with fewer side effects. We will ...
Landscape for Treatment of Metastatic Melanoma Is Expanding
Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...
SIDEBAR: Expect Questions from Your Patients
For now, genomic sequencing seems to have a greater presence in the news than in the clinic. What can physicians tell their patients who ask about genetic testing to identify mutations driving cancer growth? “The real answer is that when you get down to it, genomics is like any other test,”...
Genomics vs Site of Cancer Origin as Basis for Treatment of Cancer Is ‘False Dichotomy’
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. Despite recent news reports...
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...
Symposium Focuses on Policy Issues in Personalized Cancer Care
“What is the biggest barrier to progress in personalized medicine?” asked moderator Anna Barker, PhD, leading a panel discussion at a recent meeting convened by the Washington-based advocacy group, the Personalized Medicine Coalition, with the American Association for Cancer Research and Feinstein...
Information Service Provides Innovative Resource for Patients and Providers
Jennifer Levin Carter, MD, MPH is Founder and President of N-of-One. A board-certified internist and entrepreneur, she has more than 20 years of experience evaluating existing and emerging markets, new medical technologies, and early-stage companies in the health-care field. Formerly, Dr. Carter...
Supportive Care Experts Explore 30 Years of Progress in the Field
Thirty years ago, when the first supportive care meeting as a forerunner of the Multinational Association of Supportive Care in Cancer (MASCC) Symposium was held in New York, supportive care was largely ignored, with little discussion at major cancer meetings, which focused primarily on...
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...
Everolimus Approved for Advanced Breast Cancer
The FDA has approved everolimus tablets (Afinitor) for use in combination with exemestane to treat postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer after failure of treatment with letrozole or anastrozole. The approval was based on a randomized,...
FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma
Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have...
FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy
The FDA has approved sodium picosulfate, magnesium oxide, and citric acid (Prepopik) to help cleanse the colon in adults preparing for colonoscopy, Ferring Pharmaceuticals announced. The new solution is a low-volume, dual-acting stimulant and osmotic laxative. The FDA approval is based on data from ...
Biokine Therapeutics Awarded FDA Orphan Drug Designation for Mobilization of Stem Cells in Patients with Cancer
Biokine Therapeutics Ltd announced that it has received Orphan Drug designation from the FDA for BKT140, a highly selective chemokine receptor antagonist that induces mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in...
FDA Approves Ziv-aflibercept for Metastatic Colorectal Cancer
The FDA has approved ziv-aflibercept (Zaltrap) for use in combination with a FOLFIRI (leucovorin, fluorouracil, irinotecan) chemotherapy regimen to treat adults with colorectal cancer. Ziv-aflibercept is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients ...
Rethinking the Role of PSA Screening in Public Health
Population screening to identify preclinical disease is considered a central factor in the decades-long decrease in mortality seen in certain cancers. However, hope in the face of deadly disease can sometimes blind us to the scientific evidence. According to the recent U.S. Preventive Services Task ...
New Agents That Improve Efficacy Can Also Increase Morbidity and Treatment-related Mortality
Newly approved anticancer drugs that lead to improvements in efficacy can also lead to increased morbidity and treatment-related mortality, according to a study in the Journal of Clinical Oncology. The investigators conducted a meta-analysis of 38 randomized controlled trials evaluating agents...
It’s Time to Get Ready for New Medicare Reporting Requirements
As if you didn’t already have enough to worry about, now add this: If your practice doesn’t meet the requirements of the Physicians Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive, you don’t just miss out on the bonuses the programs offered as incentive in recent years....
Liposomal Vincristine Approved in Acute Lymphoblastic Leukemia
The FDA has approved vincristine sulfate liposome injection (Marqibo) to treat adults with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Administered once a week, liposomal vincristine is approved for patients whose leukemia has relapsed two or more times, or whose leukemia...
FDA Approves New Drug for Late-stage Prostate Cancer
The FDA has approved enzalutamide (Xtandi) to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for patients with prostate cancer previously treated with docetaxel, enzalutamide was...
New Indication for Cetuximab plus FOLFIRI to Treat EGFR-positive, Wild-type KRAS 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 In July 2012, cetuximab (Erbitux) was approved for use...
FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer
Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer ...
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...
FDA Issues New Safety Alert on Reumofan Plus and Reumofan Plus Premium
In August 21, the FDA issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain...
First Drug for Children with Rare Brain Tumor Approved
The FDA approved a new pediatric dosage form of everolimus (Afinitor Disperz) to treat the rare brain tumor called subependymal giant cell astrocytoma (SEGA). This is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended...
FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia
The FDA has approved bosutinib (Bosulif) to treat chronic myelogenous leukemia (CML). The drug is intended for patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive CML who are resistant to or who cannot tolerate other therapies, including imatinib (Gleevec). The...
Another Tyrosine Kinase Inhibitor Joins the Lineup in Renal Cell Carcinoma
The novel tyrosine kinase inhibitor tivozanib was superior to sorafenib (Nexavar) for the treatment of advanced renal cell carcinoma in the phase III TIVO-1 trial.1 Tivozanib is a potent, selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, with a long half-life that is...
Evidence Is Changing Colorectal Cancer Treatment Landscape
Key colorectal cancer studies presented at this year’s ASCO Annual Meeting are changing the treatment landscape in this disease, according to Michael Overman, MD, of The University of Texas MD Anderson Cancer Center, who reviewed the data at the Best of ASCO San Diego meeting. The mix included...
Will Carfilzomib Add Value to Multiple Myeloma Treatment?
Carfilzomib (Kyprolis), the next-generation proteasome inhibitor recently approved by the FDA for relapsed/refractory multiple myeloma, showed strong activity in the front-line setting when paired with lenalidomide (Revlimid) and low-dose dexamethasone (CRd).1 The study evaluated stringent complete ...
Which Rituximab-based Regimen Works Best in Non-Hodgkin Lymphoma?
The treatment of non-Hodgkin lymphoma (NHL) patients has been recently informed by several important studies, which were discussed at the Best of ASCO Boston meeting by Michael E. Williams, MD, of the University of Virginia Cancer Center in Charlottesville. Bendamustine Outperforms R-CHOP in NHL...
SIDEBAR: Browsing the Anti-HER2 Options
“Where do current findings leave us in terms of anti-HER2 therapy options?” asked Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Center, Boston, who moderated the Best of ASCO Boston meeting. New drugs are joining trastuzumab (Herceptin) and lapatinib (Tykerb), and there will be some juggling...
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...
2012 Is ‘Banner Year’ for Research on Symptom Management
The year 2012 was “a banner year for symptom management,” according to Debra L. Barton, RN, PhD, of the Mayo Clinic, Rochester, Minnesota, who presented data on patient and survivor care at the Best of ASCO San Diego meeting. “I have been doing symptom management for about 20 years, and it seems...
Memorial Sloan-Kettering Cancer Center Appoints José Baselga, MD, PhD, New Physician-in-Chief
Memorial Sloan-Kettering Cancer Center announced that José Baselga, MD, PhD, has been named Physician-in-Chief of Memorial Hospital. Currently, Dr. Baselga is Chief of the Division of Hematology/Oncology at Massachusetts General Hospital (MGH) and Associate Director of the MGH Cancer Center....
New Studies Explore Exposure to Cancer-causing Agents
Key studies on cancer epidemiology and prevention delivered both reassuring and not-so-reassuring findings on exposure to agents believed to be cancer-promoting. Kala Visvanathan, MD, MHS, of The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine and School of Public Health, Baltimore,...
For Advanced Sarcomas, New Agents Prolong Remission but Not Survival
“We are beginning to understand the molecular biology underlying a portion of the 80 or so subtypes of sarcomas, and we hope this will lead to subtype-specific treatments,” said William D. Tap, MD, of Memorial Sloan-Kettering Cancer Center, New York, at the Best of ASCO Boston meeting. “And in...
