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Showing 3351 - 3400Fulfilling 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...
Roswell Park Cancer Institute Partners With Cuban Scientists to Develop Lung Cancer Vaccine
Just 4 months after President Barack Obama’s announcement in December 2014 that there would be an easing of the trade embargo between the United States and Cuba, a deal was struck between Roswell Park Cancer Institute in Buffalo, New York, and the Center for Molecular Immunology (CIM) in Havana,...
Our Patients Are the True Heroes of Cancer Research
A few weeks ago, I read an op-ed1 in The New York Times written by Stan Collender, a patient with Merkel cell carcinoma, a rare and aggressive type of skin cancer. In his article, he described his participation in a clinical trial for a new drug he is hoping will stem progression of his cancer and...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
Bristol-Myers Squibb and AbbVie recently announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
FDA Grants Regular Approval to Brentuximab Vedotin in High-Risk Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced. The approval is...
FDA Approves Rolapitant for Prevention of Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) approved rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Rolapitant is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of...
Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
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 September 2, 2015, rolapitant (Varubi) was approved for use in...
Making Their Voices Heard: 118 Oncologists Speak Out About Stemming the High Cost of Cancer Drugs
In a bold move to shed light on the ramifications of the ever-increasing cost of cancer drugs for patients with cancer and for the health-care system, 118 prominent oncologists came together to write a commentary in Mayo Clinic Proceedings detailing their concerns.1 To learn more about these...
Focus on Geriatric Oncology: ASCO Prepares for an Aging Nation
The United States—and much of the world—is experiencing unprecedented demographic shifts in the population of older people, defined as people age 65 and over. In 2012, the population of older people in the United States reached a never-before seen height of 43.1 million, a number that will more...
ASCO Statement: Improving the Evidence Base for Treating Older Adults With Cancer
Older persons are the fastest-growing segment of the U.S. population and account for the majority of cancer diagnoses and deaths and the majority of cancer survivors. However, since this population is underrepresented in clinical trials, the evidence base for treating older patients is poor. As...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. Mechanism of Action The new oral agent is a...
NCCN Turns 20: Value-Based Care Has Arrived
Twenty years ago, the National Comprehensive Cancer Network (NCCN) began as a cooperative effort of 12 prestigious cancer centers, working to define and promote national guidelines for the care of patients with cancer. A major goal was to encourage uniformity in the management of malignant...
American Cancer Society Awards 2015 Medals of Honor
The American Cancer Society has bestowed its highest honor on four individuals and one foundation during the Society’s 2015 Medal of Honor ceremony and celebration dinner in Washington, DC. The Medal of Honor is awarded to those who have made the most valuable contributions and impact in the fight...
Trifluridine/Tipiracil in Previously Treated 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. On September 22, 2015, trifluridine/tipiracil (Lonsurf) was...
FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the Optune tumor-treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include surgery,...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell death-ligand 1 (PD-L1)....
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit ...
FDA Approves Use of Nivolumab in Metastatic Nonsquamous Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the PD-1/PD-L1...
Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
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 September 30, 2015, the U.S. Food and Drug Administration...
FDA Approves First Oncolytic Viral Therapy in the United States
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for talimogene laherparepvec (Imlygic), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma...
Shadowed by Cancer
Although genetic testing has not turned up any inherited mutations that might explain the number of cancers that have plagued my immediate family, over the past 15 years, I have lost my father, aunt, and sister to the disease. In 2001, my husband, Wayne, died of acute promyelocytic leukemia, and...
Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia
Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the company’s investigational antibody-drug conjugate inotuzumab ozogamicin for acute lymphoblastic leukemia (ALL). The FDA’s decision was based on the results of the phase III ...
Ovarian Cancer Trialists Forming Work Group to Standardize Definition of Pathologic Complete Response
Ovarian cancer clinical trialists are forming a working group to develop a standard definition of pathologic complete response in ovarian cancer treated with neoadjuvant chemotherapy. Such agreement within the field potentially would enable the U.S. Food and Drug Administration (FDA) to consider...
National Coalition for Cancer Survivorship Honors Richard Pazdur, MD, and Ellen Goodman
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. NCCS Chief Executive Officer, Shelly Fuld Nasso, welcomed attendees to the special awards reception. NCCS Public Service Leadership Award The...
FDA Approves Ipilimumab in Adjuvant Treatment of Stage III Melanoma
On October 28, 2015, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody ipilimumab (Yervoy) for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including ...
FDA Approves Liposomal Irinotecan for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration has approved irinotecan liposome injection (Onivyde), in combination with fluorouracil (5-FU) and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The effectiveness of...
