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Showing 3301 - 3350Study Finds Websites That Market Personalized Cancer Care Services Overemphasize Benefits
A recent analysis of 55 Internet websites marketing a broad range of tests and services that promise the ability to personalize cancer treatment has found that the websites often overemphasize their purported benefits and downplay their limitations. In addition, the study results show that the...
Herbal Supplements: Increasing Problems
In Don Quixote, the 1605 Spanish literary masterpiece by Miguel Cervantes, “Balsam of Fierabras” is mentioned often as a therapeutic panacea. It calls for mixing rosemary, wine, oil, and salt. As the story goes, the knight relied heavily on this herbal preparation to relieve him of pain from the...
Dinutuximab Combination Approved for Pediatric High-Risk Neuroblastoma
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (Unituxin), a monoclonal antibody targeting glycolipid GD2, as part of first-line therapy for pediatric patients with high-risk neuroblastoma. A chimeric monoclonal antibody that binds to the surface of neuroblastoma cells,...
FDA Launches Drug Shortages Mobile App
Today, the U.S. Food and Drug Administration (FDA) launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages, and discontinuations of drug products....
FDA Takes Steps to Simplify Compassionate Use Process, Invites Comment
The U.S. Food and Drug Administration (FDA) introduced a more streamlined form for requesting permission for patient access to investigational drugs outside of clinical trials. The new form is available for comment in a draft guidance for industry entitled “Individual Patient Expanded Access...
ASCO Supports FDA’s Proposed Regulation of Laboratory Developed Tests
In comments submitted to the U.S. Food and Drug Administration (FDA), ASCO expressed its support for the agency’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” ASCO also strongly recommends that the agency proceed with regulatory authority in a way that...
FDA Names Geoffrey Kim, MD, Director of the Division of Oncology Products
The U.S. Food and Drug Administration (FDA) recently announced the appointment of Geoffrey Kim, MD, as Director of the Division of Oncology Products 1 (DOP1) in the Office of Hematology Oncology Products. Dr. Kim assumed this position effective March 22, 2015. Dr. Kim previously served as the...
Development and Approval of Biosimilar Products
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director...
Many Cancer Patients at Risk for Hepatitis B Virus Reactivation
In 2015, no cancer patients should be cured of their malignancy only to die of reactivation of hepatitis B virus (HBV),” according to Anna S. Lok, MD, the Alice Lohrman Andrews Research Professor in Hepatology and Director of Clinical Hepatology at the University of Michigan, Ann Arbor. “I...
Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA ...
Nivolumab in Metastatic Squamous Non–Small Cell Lung Cancer After Platinum Therapy
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 March 4, 2015, the anti–programmed cell death protein 1 (PD-1) ...
FDA Approves Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis
The U.S. Food and Drug Administration (FDA) has approved Astellas’ New Drug Application for the use of isavuconazonium sulfate (Cresemba), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as...
Biosimilar Filgrastim-sndz in Filgrastim Indications
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 March 6, 2015, the granulocyte colony-stimulating factor...
FDA Approves Nivolumab to Treat Metastatic Squamous NSCLC
The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that binds to the...
FDA Approves First Biosimilar Product Filgrastim-Sndz
The U.S. Food and Drug Administration (FDA) has approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
Dinutuximab in Pediatric High-Risk Neuroblastoma
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 March 10, 2015, the chimeric monoclonal antibody dinutuximab...
The ASCO Post Replies
Nivolumab (Opdivo) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of lung cancer on March 4, 2015, before clinical data from the pivotal trials (CheckMate 017 and CheckMate 063) were presented at a major oncology conference or published in a peer-reviewed journal....
Widespread Use of Docetaxel Preceded Phase III Evidence of Usefulness in Patients With Metastatic Prostate Cancer
Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than the standard of care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and...
Expect Questions About Cold Caps to Spare Hair During Chemotherapy
For patients who have confronted a diagnosis of cancer, then endured weeks of chemotherapy, it would seem that losing their hair would not be a big concern. But for many patients, it can be. “You have to spend a year either putting on wigs or announcing to the world that you’ve had chemotherapy,”...
Scalp Cooling Caps Offer Option to Prevent Hair Loss During Chemotherapy
Hair loss remains one of the most dreaded side effects of chemotherapy, particularly for women. Scalp cooling caps worn by patients during chemotherapy infusion and for brief periods of time before and after offer these patients an option to preserve 50% or more of the hair on their heads. Although ...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated ...
FDA’s Biosimilar Product Approval Process: A Closer Look
In March, the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as a biosimilar to U.S.-licensed filgrastim (Neupogen). It is the first biosimilar product to be approved in the United States and will increase treatment options for people living with cancer. The FDA considers ...
In Search of ‘Just’ Prices: Questioning the High Cost of New Cancer Drugs
As the oncology community begins the slow and often difficult-to-define transition from volume to value in the delivery of cancer care, the relationship between the price and value of certain high-priced cancer drugs is getting more scrutiny. We generally correlate the efficacy of a new drug and...
Breast Cancer Management in Review
With the field of breast oncology as complex as ever, a brief update of the latest findings impacting breast cancer treatment seems timely. To that end, I have assembled highlights from a collection of newsworthy studies featured over the past year and into early 2015. Part 1 of this review, which...
Richard Pazdur, MD, and Anthony S. Fauci, MD, Included in Fortune’s List of the World’s 50 Greatest Leaders
Richard Pazdur, MD, Director of the Office of Oncology and Hematology Products at the U.S. Food and Drug Administration (FDA) was named one of the world’s 50 greatest leaders by Fortune Magazine. The list also included names such as Pope Francis, Apple CEO Tim Cook, Chief Justice of the United...
FDA Approves Ramucirumab for Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) today approved ramucirumab (Cyramza) for use in combination with FOLFIRI (leucovorin, fluorouracil, irinotecan) for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab (Avastin)-,...
ASCO Submits Comments to FDA on Next-Generation Sequencing Tests
ASCO submitted comments to the U.S. Food and Drug Administration (FDA) on its white paper, “Optimizing FDA’s Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests.” The Society expressed its support of the exploration of new regulatory strategies for next-generation sequencing...
Combining Antiangiogenic and Vascular-Disrupting Agents Improves Progression-Free Survival in Persistent Ovarian Cancer
“Bevacizumab [Avastin] prevents new blood vessels from growing, but what about the blood vessels that are already in the tumor?” Presenting that challenge to participants at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in Chicago, Bradley J. Monk, MD, of the University of...
Groups Join Together to Form Ovarian Cancer Research Team
Stand Up To Cancer , Ovarian Cancer Research Fund, Ovarian Cancer National Alliance, and National Ovarian Cancer Coalition, along with the American Association for Cancer Research (AACR), announced the formation of a “Dream Team” devoted to ovarian cancer research at the AACR Annual Meeting 2015....
Combination Immunotherapy Better Than Monotherapy in Advanced Melanoma
As clinical research struggles to keep up with the pace of new immunotherapies, one of the burning questions is how best to combine the new drugs. A new study found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) is superior to ipilimumab alone as front-line therapy for untreated ...
Crizotinib Receives Breakthrough Therapy Designation for ROS1-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to crizotinib (Xalkori) for the potential treatment of patients with ROS1-positive non–small cell lung cancer (NSCLC). Crizotinib currently is FDA-approved for the treatment of patients with metastatic NSCLC...
ASCO Releases 2015 Report on The State of Cancer Care in America
In March, ASCO published its second annual report, The State of Cancer Care in America: 2015.1 Its findings show a mixed landscape, on the one hand, spotlighting advances in therapy and improving survival rates, but on the other, describing a cancer care system under stress from increasing demand...
Practice-Changing Study: Pembrolizumab Outperforms Ipilimumab in Advanced Melanoma
Pembrolizumab (Keytruda) proved superior to ipilimumab (Yervoy) for the treatment of unresectable advanced melanoma in the global phase III KEYNOTE-006 trial. Pembrolizumab significantly improved overall survival, progression-free survival, and overall response rate compared with ipilimumab, which...
Remembering Multiple Myeloma Patient Advocate Michael S. Katz, MBA
I first met Michael Katz, MBA, in 2004, 3 years after my brother, Dom, was diagnosed with multiple myeloma, and we were at a crossroads in his care and needed advice. Although an experimental regimen of thalidomide (Thalomid) and dexamethasone had successfully put Dom in remission for a year (the...
Building a Better Federal Oncology Workforce
The process of delivering novel treatments for patients with cancer involves a multifaceted and long-term interaction between three distinct entities: clinical researchers, who conduct the trials which test treatments; drug developers, including the pharmaceutical industry, which takes cancer drugs ...
Cobas KRAS Mutation Test Receives FDA Approval
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid...
FDA Accepts Supplemental Biologics License Application for Nivolumab in Patients With Previously Untreated Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority...
FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an...
Venetoclax Receives Breakthrough Therapy Designation in Relapsed/Refractory CLL With 17p Deletion
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to AbbVie’s investigational agent venetoclax (ABT-199) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in patients with 17p deletion. Venetoclax is an investigational oral B-cell...
Pembrolizumab vs Ipilimumab: Good vs Better
The treatment landscape for metastatic melanoma has recently undergone a remarkable transformation. Prior to 2011, clinicians and patients were presented with difficult decisions between therapies without proven survival benefit. Now, similarly difficult but much more hopeful choices are posed...
Welcome to Multikinase Inhibitors in Radioiodine-Refractory Thyroid Cancer
In the past 2 decades, the incidence of thyroid cancer has risen steeply, with rates now growing by 5.5% annually.1 In 2014, 62,980 new cases of thyroid cancer were diagnosed in the United States. The good news is that, overall, the prognosis of thyroid cancer remains excellent; 97.8% of patients...
Will the PVS-RIPO Poliovirus Be a Game Changer in the Treatment of Recurrent Glioblastoma?
Although the idea of using viruses to target cancer cells dates back more than 100 years, technologic advances in the genetic engineering of viruses are now making it possible to safely test oncolytic virotherapy as a valid strategy against cancer cells. One type of genetically engineered virus...
ASCO Endorses American Cancer Society Prostate Cancer Survivorship Care Guidelines
As reported in the Journal of Clinical Oncology by Matthew J. Resnick, MD, of Vanderbilt University Medical Center, and colleagues, ASCO has endorsed the 2014 American Cancer Society Prostate Cancer Survivorship Care Guidelines.1,2 The ASCO endorsement panel was co-chaired by Dr. Resnick and David...
PARP Inhibitors: The First Potential Treatment of Hereditary Ovarian Cancers
Poly(ADP-ribose) polymerase (PARP) inhibitors are one of the most exciting new classes of agents in development for the treatment of ovarian cancer. Olaparib (Lynparza), the lead oral PARP inhibitor, received accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of...
PARP Inhibitors Have ‘Clear Benefit’ for Patients With Ovarian Cancer and BRCA Mutations, but When and at What Cost?
PARP inhibitors offer a promising alternative for targeted therapy in ovarian cancer” and have “clear benefit in BRCA-mutation carriers,” but questions remain about when is the best time to use them and the cost-effectiveness of maintenance therapy, Elizabeth M. Swisher, MD, of the University of...
Expert Point of View: Elaine Mardis, PhD
Elaine Mardis, PhD, Co-director of The Genome Institute at Washington University School of Medicine, St. Louis, commented on the IMPaCT trial and the constraints of the U.S. health-care system. “The correct clinical trial has not yet been performed to demonstrate the clinical utility of genomic...
Andrew C. von Eschenbach, MD, Went From the Front Lines of Cancer Care to a Bird’s-Eye View of the Changing Oncology Landscape
At the end of the day, I’m still a kid from South Philly,” Andrew C. von Eschenbach, MD, former Director of the National Cancer Institute (NCI) and Commissioner of the U.S. Food and Drug Administration (FDA), told The ASCO Post. Dr. von Eschenbach is the product of a closely knit yet culturally...
Bruce A. Chabner, MD, and His Innovative Pharmacology Research Led to the Development of Practice-Changing Therapies
Numerous challenges and milestones mark the course of an oncology career. Community doctors remember special patients, often speaking about a singular bond that is unique among a profession that deals with life and death daily. Researchers recount long hours of seeming futility and then the...
ASCO Announces First-Ever Clinical Trial
ASCO announced its first-ever clinical trial, which will offer patients with advanced cancer access to molecularly targeted cancer drugs and collect “real-world” data on clinical outcomes, to help learn the best uses of these drugs outside of indications approved by the U.S. Food and Drug...
