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Showing 3401 - 3450FDA 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...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. Trabectedin is a novel marine antineoplastic alkaloid with a unique mechanism ...
Daratumumab Approved in Multiple Myeloma
The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome...
FDA Approves Cobimetinib in Combination With Vemurafenib for Metastatic Melanoma
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval...
A Selfless Act
The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology (JCO). These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
ASCO Launches TAPUR to Assess the Off-Label Use of Targeted Therapies for Patients With Advanced Cancers
Two years ago, Richard L. Schilsky, MD, FACP, FASCO, Chief Medical Officer of ASCO, proposed a unique clinical trial concept during an educational session on the challenges of delivering precision medicine services in a community setting at ASCO’s Annual Meeting. The idea was to design a clinical...
The Role of Botulinum Toxin in Head and Neck Cancer
Head and neck cancer and its treatment can result in a variety of neuromuscular and musculoskeletal pain and functional sequelae. Commonly seen conditions in patients with the disease include neck pain and spasm, hemifacial spasm, trismus, dysphonia, dysarthria, neuropathic pain, and salivary...
Talimogene Laherparepvec for Treatment of Unresectable Cutaneous, Subcutaneous, and Nodal Melanoma Lesions
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 October 27, 2015, talimogene laherparepvec (Imlygic) was...
Ipilimumab in Adjuvant Treatment of Cutaneous Melanoma With Nodal Involvement
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 October 28, 2015, ipilimumab (Yervoy) was approved for adjuvant ...
The State of Progress in Hematologic Malignancies
The number of targeted therapies approved by the U.S. Food and Drug Administration (FDA) in the treatment of a variety of cancers, especially hematologic malignancies, continues to rise. In 2014 alone, 4 of the 10 new agents directed at discrete molecular targets approved by the FDA were for blood...
Lenvatinib in Refractory Thyroid Cancer: Survival Benefit or Not?
In the original phase III SELECT trial, no overall survival benefit was observed for lenvatinib (Lenvima) vs placebo in progressive radioactive iodine–refractory differentiated thyroid cancer. Overall survival was a secondary endpoint in that trial. However, in an updated analysis of SELECT, which...
Antoni Ribas, MD, PhD, Receives NCI Outstanding Investigator Award
UCLA Jonsson Comprehensive Cancer Center member Antoni Ribas, MD, PhD, has received a National Cancer Institute (NCI) Outstanding Investigator Award of $4.2 million in recognition of his research conducted in the development of new immunotherapies that utilize the human body’s own natural defenses ...
Nationally Regarded Oncology Nurse Practitioner, Mary Pazdur, RN, MSN, Remembered by Friends and Colleagues
Oncology nurse practitioner Mary Pazdur, RN, MSN, spent her professional life bettering the clinical care and outcomes of cancer patients, culminating in her career at the National Cancer Institute (NCI), in the Laboratory of Tumor Immunology and Biology, working with patients on cancer vaccine...
Yet Another Reason Why Dogs Are Our Best Friends
BookmarkTitle: Heal: The Vital Role of Dogs in the Search for Cancer CuresAuthor: Arlene WeintraubPublisher: ECW PressPublication date: October 13, 2015Price: $16.95; paperback, 240 pages Comparative oncology, a fairly recent addition to the ever-evolving world of cancer research, studies the...
Ixazomib in Previously Treated 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 November 20, 2015, ixazomib (Ninlaro) was approved by the U.S....
Osimertinib for Metastatic EGFR T790M–Mutant Non–Small Cell Lung Cancer After EGFR Inhibitor 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 November 13, 2015, osimertinib (Tagrisso) was granted...
A Blueprint for Drug/Diagnostic Development: Expansion and Use of Curated Genetic Databases
In a continuation of a 2014 conference that explored regulatory considerations and strategies for next-generation sequencing, the Friends of Cancer Research, with support from Alexandria Real Estate Equities, Inc, Pasadena, California, met to discuss the issues and problems of coordinating drug and ...
FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC
The FDA approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC. Necitumumab is a recombinant human IgG1...
Cobimetinib in BRAF-Mutant Unresectable or Metastatic Melanoma in Combination With Vemurafenib
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 November 10, 2015, the U.S. Food and Drug Administration...
Trabectedin in Liposarcoma/Leiomyosarcoma: The Drug Is Approved, Now the Real Drug Development Begins!
Led by George Demetri, MD, of Dana-Farber Cancer Institute, Boston, expert medical oncology investigators from leading academic sarcoma centers and Janssen Pharmaceuticals employees performed a phase III trial in order to provide evidence for the U.S. Food and Drug Administration (FDA) approval of...
Nivolumab Receives Two FDA Approvals in November
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA)...
