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Showing 3351 - 3400Richard 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...
Fulfilling NCI’s Commitment to Supporting the Best Science
On April 1, 2015, Douglas R. Lowy, MD, became Acting Director of the National Cancer Institute (NCI), succeeding Harold Varmus, MD, who left NCI to join the faculty of Weill Cornell Medical College in New York. (See “The Next Step in a Storied Career,” in the May 25, 2015 issue of The ASCO Post.)...
Over 30 Organizations, Including ASCO, Call for FDA to Regulate E-Cigarettes
ASCO, together with 30 organizations, have sent a letter to President Obama asking for his leadership in giving the U.S. Food and Drug Administration (FDA) the authority to regulate e-cigarettes and other currently unregulated tobacco products. The 2009 Family Smoking Prevention and Tobacco Control ...
Clinical Trials, Drug Costs, and Restoring the Primacy of the Patient Volunteer
“What’s past is prologue.” —William Shakespeare Today, a cancer drug under study in a clinical trial is commonly provided for a finite period of time after the study closes to accrual. If that drug were not yet U.S. Food and Drug Administration (FDA)-approved when the study began, the complimentary ...
Redefining Cancer
The ability to interrogate cancer cells at the genomic, proteomic, immunologic, and metabolomic levels will transform oncology care from one that relies mainly on trial-and-error treatment strategies based on the anatomy of the tumor to one that is more precisely based on the tumor’s molecular...
Deciphering the Genetic Variability of Cancer to Advance Precision Oncology Care
In 2014, Memorial Sloan Kettering Cancer Center (MSKCC) in New York opened the Marie-Josée and Henry R. Kravis Center for Molecular Oncology with the sole purpose of expediting the translation of novel molecular discoveries into clinical innovations to turn the goal of precision oncology care into...
Single-Agent Daratumumab Activity Deemed ‘Remarkable’ in Refractory Multiple Myeloma
Heavily pretreated patients with multiple myeloma achieved rapid, durable, and deepening responses to the anti-CD38 monoclonal antibody daratumumab, in a phase II study presented at the 2015 ASCO Annual Meeting.1 “Daratumumab showed remarkable single-agent activity in heavily pretreated and...
Oncolytic Immunotherapy in Melanoma: It’s Not All About PD-1
The benefit from immune-directed therapies in patients with advanced melanoma is not limited to the exploding field of checkpoint inhibitors. According to Robert Andtbacka, MD, Associate Professor of Surgical Oncology, at the Huntsman Cancer Institute at the University of Utah, Salt Lake City,...
Cost of Immunotherapy Projected to Top $1 Million per Patient per Year
If new immunotherapy combinations were administered to the half a million Americans dying of cancer each year, the nation’s price tag for treating them—for just 1 year—could top $174 billion, according to projections by Leonard Saltz, MD, Chief of Gastrointestinal Oncology and Chair of the Pharmacy ...
Pacritinib for Myelofibrosis: Effective in Patients With Thrombocytopenia
An emerging JAK inhibitor, pacritinib, appears not only effective in a broad population of patients with myelofibrosis but also among a subset with very low platelet counts, investigators from the global phase III PERSIST-1 trial reported at the 2015 ASCO Annual Meeting.1 “There is a huge unmet...
Biosimilars: Questions Remain
Biosimilars are biologic drugs that are similar to an already established “reference” or “innovator” biologic drug product and can be manufactured when an original biologic drug product’s patent expires. Reference to the innovator product is an integral component of approval for a biosimilar. The...
FDA’s Pregnancy Category Labeling
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, FDA supervisory toxicologist Todd Palmby, PhD, and pharmacologist Eias Zahalka, PhD, MBA, discuss the approach taken in the Office of ...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...
Translational Research: Dogs and Humans Nearly Interchangeable in the Laboratory
“Between animal and human medicine there is no dividing line—nor should there be. The object is different but the experience obtained constitutes the basis of all medicine.” — Rudolf Virchow (1821–1902) Everyone has seen photographs of people who look like their dogs: the young woman with long...
2015–2016 ASCO President Julie M. Vose, MD, MBA, FASCO: Leading During a Year of Historic Changes
Julie M. Vose, MD, MBA, FASCO, began her term as the 2015–2016 President of ASCO at the 2015 Annual Meeting on June 1, 2015. Dr. Vose, a leading expert in the treatment of patients with lymphoma, is the current Neumann M. and Mildred E. Harris Professorial Chair and Chief of the Oncology/Hematology ...
ODAC Discussion ‘Constructive’ About Necitumumab for Squamous NSCLC
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) favored the approval of necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). In...
FDA Grants Orphan Drug Designation to Antitropomyosin Drug for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Novogen Limited’s chemotherapy candidate drug Anisina for neuroblastoma. Anisina is a small molecule belonging to a family of compounds called antitropomyosins. It has been designed to inhibit Tpm3.1, a structural...
Value: What Do We Mean, Who Should Decide?
Oscar Wilde famously defined a cynic as “a man who knows the price of everything and the value of nothing.” I do not think that oncologists need to be as cynical as this, but it was very appropriate that a major theme of this year’s ASCO Annual Meeting was the concept of “value.” It is clear that...
Johnson & Johnson Creates Independent Bioethics Panel to Evaluate Compassionate Drug Use Requests
In May 2015, Johnson & Johnson announced its partnership with New York University (NYU) School of Medicine in New York to create a first-of-its kind independent bioethics panel to review requests made to the company for compassionate use of an investigational drug and determine how the company...
Calculating the Value of Cancer Drugs
For nearly a decade, Peter B. Bach, MD, MAPP, Director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York, has been a leading voice in sounding the alarm over the escalating cost of cancer drugs and in seeking a solution to the problem. In 2012, Dr....
Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
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 July 24, 2015, carfilzomib (Kyprolis) was approved for use in...
FDA Approves Sonidegib for Locally Advanced Basal Cell Carcinoma
The U.S. Food and Drug Administration (FDA) approved sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy. The approval was based on...
Dactinomycin Formulation Gets Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to NanoSmart Pharmaceuticals’ novel formulation of dactinomycin for the treatment of Ewing sarcoma, a rare type of childhood bone cancer. The designation was granted on the basis of a plausible hypothesis that the novel ...
FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib...
FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. In the United States, there are nearly...
‘Right to Try’ Laws: Helpful or Harmful?
Since 2014, “Right to Try” legislation has been sweeping the nation. Created to enable terminally ill patients to gain access to experimental drugs, biologics, and devices by sidestepping the approval process of the U.S. Food and Drug Administration (FDA), at press time, 22 states have enacted...
