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Showing 2401 - 2450FDA Approves Rucaparib and Companion Genetic Test in Advanced Deleterious BRCA-Mutated Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to rucaparib (Rubraca) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved...
WCLC 2016: Phase II LUME-Meso Trial on Oral Nintedanib in Mesothelioma Demonstrates Meaningful Clinical Benefit
The LUME-Meso phase II trial in patients with unresectable malignant pleural mesothelioma met its primary endpoint of progression-free survival. The data, presented at the 17th IASLC World Conference on Lung Cancer (WCLC) in Vienna (Abstract 4191 #OA22.02), showed nintedanib (Ofev) plus...
SABCS 2016: Scalp-Cooling Device Safe and Effective in Reducing Chemotherapy-Induced Alopecia in Women With Breast Cancer
Although adjuvant chemotherapy decreases the risk of breast cancer recurrence, it is associated with distressing side effects, including hair loss. A prospective randomized trial evaluating the safety and efficacy of the Orbis Paxman Hair Loss Prevention System (OPHLPS), a scalp-cooling device that ...
Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs
On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid...
Friends of Cancer Research Rethinks Traditional Clinical Trials
Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is ...
NCCN Launches Campaign to Eradicate Fatal Vincristine Errors
It is uniformly fatal and impossible to undo. When the chemotherapy drug vincristine is placed in a syringe and injected intrathecally—into the spinal fluid—the patient always dies. And despite safety guidelines and labels, deaths continue to occur. Now the National Comprehensive Cancer Network®...
ASCO’s TAPUR Study Now Has More Than 100 Participants Receiving Treatment Drugs and 25 New Clinical Trial Sites
More than 100 participants are now enrolled on study drug in ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study. The trial launched in March 2016 at 37 sites, and in November, it welcomed its newest participating clinical sites: Cancer Treatment Centers of America®,...
Reagan-Udall Foundation Announces Appointments of Ellen V. Sigal, PhD, and Richard L. Schilsky, MD
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the FDA, has elected Ellen V. Sigal, PhD, as its new Chairman, and Richard L. Schilsky, MD, as Vice ...
The FDA Ensures Quality and Safety of Generic Drugs in the United States
The U.S. Food and Drug Administration’s (FDA) generic drug program has substantially increased the availability of affordable, high-quality drugs in the United States. It is arguably the only really effective health-care cost–containment program. The more than 10,000 generic drugs currently...
Concerns About Safety of Generic Oncology Drugs Made in Developing Countries
In an article in The Lancet Oncology, Y. Tony Yang, ScD, of George Mason University, Charles L. Bennett, MD, PhD, MPP, of the University of South Carolina and colleagues from the United States, Europe, and Japan examined clinical, policy, safety, and regulatory considerations for generic oncology...
New Treatments for Lung Cancer in 2016
With drug approvals for immunotherapy in the first- and second-line settings, breakthroughs in targeting epidermal growth factor receptor (EGFR) mutations, and the rapid evolution of therapies that target anaplastic lymphoma kinase (ALK) rearrangements, 2016 has been an extraordinary year for lung...
FDA Approves Daratumumab in Combination Therapy for Patients With Multiple Myeloma Receiving at Least One Prior Treatment
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior...
ASH 2016: New Data Shed Light on Potential Advantages of Pacritinib for Patients With Myelofibrosis
Compared with standard therapy, pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, according to a late-breaking study presented by Mascarenhas et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition...
FDA Grants sBLA to Pembrolizumab for the Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for...
FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL
The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no ...
FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer
On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted...
FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from an...
FDA Approves Daratumumab in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Multiple Myeloma
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior...
Understanding Biosimilars and Their Impending Role in Oncology Care
Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S....
Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
Anti–PD-1 Contenders in Advanced Urothelial Cancer
Immunotherapy with anti–PD-1 (programmed cell death protein 1) and anti–PD-L1 (programmed cell death ligand 1) agents continues to advance in metastatic urothelial cancer, with positive showings in two clinical trials presented at the 2016 European Society for Medical Oncology (ESMO) Congress. The...
Clinical Strategies for Improving Endocrine Therapy in Metastatic Breast Cancer
Most women with hormone receptor–positive breast cancer receive endocrine therapy as part of their treatment, but “the reality is that patients who receive antihormone therapy in the metastatic disease setting ultimately develop disease progression, ” William J. Gradishar, MD, stated at the 18th...
Cautious Optimism About Olaratumab in Soft-Tissue Sarcoma
The current plethora of drugs in development for oncology is leading to the testing of novel agents in common as well as rare diseases. Targeted therapies have been a focus of great interest in soft-tissue sarcomas, with testing of a variety of oral tyrosine kinase inhibitors leading to the...
Pembrolizumab as First-Line Therapy in Metastatic NSCLC: Practice-Changing Implications of KEYNOTE-024 Trial
We are in the midst of a paradigm shift in lung cancer. In the past 2 years, the anti–programmed cell death protein 1 (anti–PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) were found to improve overall survival in the second-line setting compared with docetaxel for patients with...
ASCO’s TAPUR Study Has More Than 100 Participants Receiving Treatment Drugs and 25 New Clinical Trial Sites
More than 100 participants are now enrolled on study drug in ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study. The trial launched in March 2016 at 37 sites, and in November, it welcomed its newest participating clinical sites: Cancer Treatment Centers of America,...
SITC Publishes First Kidney Cancer Treatment Guideline to Focus on Immunotherapy
The first evidence-based consensus statement on cancer immunotherapy for the treatment of patients with the most common type of kidney cancer, renal cell carcinoma, has been published by the Society for Immunotherapy of Cancer (SITC) in the Journal for ImmunoTherapy of Cancer by Rini et al. The...
FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from an...
Modified Indication for Erlotinib in Advanced Non–Small Cell Lung Cancer
On October 18, 2016, the indication for erlotinib (Tarceva) in the treatment of non–small cell lung cancer (NSCLC) was modified to limit use to patients with tumors with specific epidermal growth factor receptor (EGFR) mutations in maintenance or second- or greater-line treatment; these mutations...
As More Biosimilars Move Toward U.S. Market, Questions Remain About Cost Savings and Uptake by Physicians and Patients
The U.S. Food and Drug Administration (FDA) approved its first biosimilar drug, filgrastim-sndz (Zarxio), in 2015, allowing it to compete with the granulocyte colony-stimulating factor filgrastim (Neupogen) to treat neutropenia in chemotherapy patients. So far, filgrastim-sndz is the only...
Roger Stupp, MD, Appointed Associate Director for Strategic Initiatives at Robert H. Lurie Cancer Center
Swiss neuro-oncologist Roger Stupp, MD, has been appointed Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. A leading authority on the treatment of primary and metastatic brain cancer, Dr. Stupp will join Northwestern...
FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin to treat adults with certain types of soft-tissue sarcoma. Olaratumab is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the first...
Combination Strategies Harness the Power of the Oncolytic Virus Talimogene Laherparepvec
The injectable oncolytic immunotherapy talimogene laherparepvec (also known as T-VEC, Imlygic) may become a valuable component of combination immunotherapy approaches in melanoma, a strategy believed to help overcome resistance of tumors to single-agent immunotherapies. “[Talimogene laherparepvec] ...
Concerns About Safety of Generic Oncology Drugs Made in Developing Countries
In a Lancet Oncology article, Yang et al examined clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the United States, Canada, European Union (EU), Japan, China, and India. Available data do not identify safety concerns in the United States, Canada, EU,...
Introduction
As expensive cancer biologics move off patent, biosimilar products are coming on board. These are highly similar versions of licensed biologics that demonstrate near-fingerprint identity to their reference products in terms of structure and potency. Biosimilars represent a major opportunity for...
Pembrolizumab Plus Chemotherapy Improves Outcomes Over Chemotherapy Alone in Advanced NSCLC
Combining immunotherapy with a standard chemotherapy doublet appears to be an attractive option for the front-line treatment of advanced nonsquamous non–small cell lung cancer (NSCLC), according to the results of a phase II study presented at the 2016 European Society for Medical Oncology (ESMO)...
Putting Patients First: My Journey in Advocacy
When I lost my only sister to breast cancer in 1986, patients like her had devastatingly few choices. Over the intervening decades, sustained commitment to biomedical research at the National Institutes of Health (NIH) and major technologic advances have led to transformative changes in cancer...
Notable Gains in Survival Achieved With Atezolizumab in Non–Small Cell Lung Cancer
The programmed cell death ligand 1 (PD-L1) inhibitor atezolizumab (Tecentriq) significantly improved overall survival, compared to docetaxel, in previously treated, advanced non–small cell lung cancer (NSCLC), according to preliminary results of the phase III OAK study. The findings are the first...
Ribociclib Granted FDA Priority Review for First-Line Treatment of Hormone Receptor–Positive/HER2-Negative Advanced Breast Cancer
On November 1, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for filing and granted Priority Review for ribociclib (LEE011) as first-line treatment of postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2...
Phase III SOLO-2 Trial Shows Significant Progression-Free Survival Benefit From Olaparib Treatment in BRCA-Mutated Metastatic Ovarian Cancer
Positive results were announced on October 26, 2016, from the phase III SOLO-2 trial, designed to determine the efficacy of olaparib (Lynparza) tablets (300 mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive, BRCA-mutated relapsed ovarian cancer. Results from the...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the...
CDC Recommends Only Two HPV Shots for Younger Adolescents
The Centers for Disease Control and Prevention (CDC) have recommended that 11- to 12-year-olds receive 2 doses of human papillomavirus (HPV) vaccine at least 6 months apart rather than the previously recommended 3 doses to protect against cancers caused by HPV infections. Teens and young adults who ...
Evaluating the FDA’s Approach to Cancer Clinical Trials
Since the announcement of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) on June 29, 2016, as part of the White House’s Cancer Moonshot, we’ve been working to further the FDA’s efforts to get new oncology products into the hands of patients. We are committed to...
FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin to treat adults with certain types of soft-tissue sarcoma. Olaratumab is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of ...
Modification of Dosage Regimen for Nivolumab in Renal Cell Carcinoma, Melanoma, and NSCLC
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 13, 2016, the U.S. Food and Drug Administration...
Atezolizumab Approved for the Treatment of Metastatic NSCLC That Has Progressed During or After Platinum-Containing Therapy
On October 18, 2016, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic...
FDA Modifies the Indication of Erlotinib in Non–Small Cell Lung Cancer to Patients With Specific EGFR Mutations
On October 18, 2016, the U.S. Food and Drug Administration (FDA) modified the indication for erlotinib (Tarceva) in the treatment of non–small cell lung cancer (NSCLC) to limit its use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. The labeling...
ESMO 2016: Ipilimumab as Adjuvant Therapy Improves Overall Survival in High-Risk Stage III Melanoma
Ipilimumab (Yervoy) as adjuvant therapy significantly improves overall survival in patients with high-risk stage III melanoma, according to the European Organisation for Research and Treatment of Cancer (EORTC) 18071 phase III trial results presented by Eggermont et al at the European Society for...
HHS Takes Steps to Provide More Information on Clinical Trials to the Public
To make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services (HHS) issued a final rule on September 19 that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov....
Expect Questions About the FDA Discouraging Use of Ovarian Cancer Screening Tests
The release of a U.S. Food and Drug Administration (FDA) Safety Communication “alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests”1 and recommending against using these tests comes not as a result of startling new studies, but from an...
