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Showing 2851 - 2900FDA 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...
FDA Approves Production of Imaging Agent to Detect Prostate Cancer
The FDA approved the production and use of Choline C 11 Injection, a positron-emission tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue ...
FDA Approves First Ultrasound Imaging System for Dense Breast Tissue
The FDA approved somo-v Automated Breast Ultrasound System (ABUS), the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The National Cancer Institute estimates that about 40% ...
FDA Approves New Treatment for Severe Neutropenia
The FDA recently approved Sicor Biotech’s tbo-filgrastim (Neutroval) to reduce the time certain patients receiving chemotherapy experience severe neutropenia. The new drug is a short-acting recombinant granulocyte colony-stimulating factor (G-CSF) agent. It is marketed as Tevagrastim in Europe,...
New Drug Application Submitted for Regorafenib to Treat GIST
Bayer HealthCare and Onyx Pharmaceuticals recently announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for the oral multikinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose...
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...
Developments in Hematologic Cancers Include New Considerations in Treating Challenging Leukemias and Multiple Myelomas
Speakers at the National Comprehensive Cancer Network (NCCN) 7th Annual Congress on Hematologic Malignancies reviewed the current standard of care for various hematologic cancers and explored new concepts in treatment. Below are highlights from presentations on chronic myelogenous leukemia (CML),...
Regorafenib Approved for Advanced Colorectal Cancer
The FDA recently approved regorafenib (Stivarga) to treat patients with metastatic colorectal cancer that has progressed after treatment. Regorafenib is a multikinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that ...
Despite Progress, Chemotherapy Drug Shortages Still Vex the Oncology Community
During the first week of November 2011, President Obama signed an Executive Order directing the FDA to take steps to help resolve the drug shortages that were affecting patient care across the country. The oncology community was hit especially hard; many of the drug shortfalls were generic...
A Series of Medical Missteps
Since the beginning of my symptoms—occasional pain on the upper left side of my abdomen, accompanied at times by nausea—which started nearly 20 years ago, my condition, pancreatic neuroendocrine tumor, either remained undetected or was completely misdiagnosed until just recently. A series of...
Novel Drug Combinations Present New Hope for Effective Treatments in Multiple Myeloma
Developing early-phase clinical trials that incorporate combinations of novel agents targeting different pathways in the hematologic cancer multiple myeloma is a leading focus of the work of Sagar Lonial, MD, Professor of Hematology and Vice Chair of Clinical Affairs in the Department of Hematology ...
AACR’s Cancer Progress Report 2012 Highlights Advances, Challenges, Opportunities
The American Association for Cancer Research (AACR) recently released its Cancer Progress Report for 2012,1 providing a snapshot of the major advances in cancer research, and highlighting the great need for continued funding for the field. “It is a new day for cancer research and cancer patients,” ...
Role of Crizotinib in Previously Treated ALK-positive Advanced NSCLC
In yet another success story for personalized medicine, a targeted therapy extended survival in patients whose cancers expressed the target. Crizotinib (Xalkori), the first-in-class ALK inhibitor, extended progression-free survival and improved response rates compared with single-agent chemotherapy ...
Will mTOR Inhibitors Change the Treatment of Endocrine-sensitive HER2-negative Breast Cancer?
For the treatment of endocrine-sensitive metastatic breast cancer, the combination of an mTOR inhibitor and an endocrine agent represents a promising new option. At the 2012 Breast Cancer Symposium, the 18-month update of BOLERO-2, which tested therapy with everolimus (Afinitor) plus exemestane,...
Nab-paclitaxel Approved in First-line Metastatic NSCLC
The FDA has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who are not candidates for ...
Novel Mechlorethamine Gel Considered Safe and Effective for Treatment of Mycosis Fungoides
A novel mechlorethamine, 0.02%, gel produced comparable or higher response rates (depending on the measurement used) than did mechlorethamine, 0.02%, compounded ointment, in a randomized controlled, multicenter study among 260 patients with stage IA to IIA mycosis fungoides, the most common form of ...
CyberKnife M6 Series Gets FDA 510(k) Clearance
Accuray Incorporated has announced that the company received 510(k) clearance from the FDA for its new CyberKnife M6 Series. The CyberKnife M6 Series features expanded clinical capabilities and reduced treatment times. The new CyberKnife M6 FIM and FM Systems, featuring the InCise Multileaf...
Rituximab Infusion Approved for NHL
The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1. Patients with clinically significant cardiovascular disease and high...
FDA Approves New Use of Pemetrexed in the Maintenance Setting for NSCLC
The FDA has expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (Alimta) for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non–small cell lung cancer (NSCLC) followed by pemetrexed maintenance in...
FDA Approves Noninvasive Radiation Therapy to Treat Pain from Bone Metastases
InSightec Ltd announced that the FDA has approved ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate since it was approved in 2004 as ...
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...
FDA Approves Omacetaxine for Chronic Myeloid Leukemia
The FDA has approved omacetaxine mepesuccinate (Synribo) to treat adults with chronic myelogenous leukemia (CML) whose cancer has progressed after treatment with at least two tyrosine kinase inhibitors. Omacetaxine is injected subcutaneously twice daily for 14 consecutive days over a 28-day cycle...
Updated Results from T-DM1 and Regorafenib Trials, plus Other Highlights from ESMO 2012
The 35th European Society for Medical Oncology (ESMO) Congress in Vienna broke all records for attendance, with about 16,000 attendees from all over the world. Some sessions were standing room only, including the Presidential Symposia, the ESMO-ASCO Joint Symposium on genomics in breast cancer, and ...
Managing Treatment Failure in Chronic Myeloid Leukemia
As John Goldman, DM, FRCP, FRCPath, FMedSci, discussed earlier, a substantial minority of patients with chronic myeloid leukemia (CML) experience treatment failure. Jorge Cortes, MD, of The University of Texas MD Anderson Cancer Center, introduced this session with two patient cases to illustrate...
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...
MSKCC’s Decision Not to Purchase New Cancer Drug Sparks Editorial and Unprecedented Actions
“At Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer: we are not going to give a phenomenally expensive new cancer drug to our patients.” That was the opening sentence of a New York Times op-ed piece written by three physicians from Memorial...
