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Showing 2451 - 2500SITC 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...
The FDA Urges Physicians and Patients to Forgo Ovarian Cancer Screening Tests
In a Safety Communication directed at women and physicians, the U.S. Food and Drug Administration (FDA) alerted women “about the risks associated with the use of tests being marketed as ovarian cancer screening tests” and recommended “against using currently offered tests to screen for ovarian...
ASCO Supports Recent Tobacco Legislation
On August 8, the U.S. Food and Drug Administration’s (FDA) rule giving the agency the authority to regulate e-cigarettes, cigars, hookahs, and pipe tobacco took effect. In May, ASCO applauded the FDA for exercising its congressionally mandated authority to regulate e-cigarettes as a crucial step in ...
Friends of Cancer Research Honors Oncology Leaders at 20th Anniversary and Announces Partnership
Friends of Cancer Research (Friends) celebrated its 20th anniversary September 21 at a special event in Washington, DC. The event honored Janet Woodcock, MD; Eric Lander, PhD; and Sean Parker. Dr. Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug...
Pearls for Managing Immune-Related Toxicities
With checkpoint inhibitors in frequent use, clinicians strive daily to balance the efficacy and toxicity of these treatments. At the 2016 Palliative Care in Oncology Symposium, Lynn M. Schuchter, MD, FASCO, the C. Willard Professor of Hematology-Oncology at the University of Pennsylvania,...
FDA Grants Breakthrough Therapy Designation for First-Line Treatment of ALK-Positive NSCLC
On October 4, 2016, the U.S. Food and Drug Administration (FDA) granted alectinib (Alecesna), an anaplastic lymphoma kinase (ALK) inhibitor, a second Breakthrough Therapy designation. This latest designation was granted for the treatment of adult patients with advanced ALK-positive non–small...
AACR’s Cancer Progress Report Hails Research Advances and Details Challenges Ahead
Although research advances in more effective therapies and diagnostics and improved screening technology over the past 2 decades have led to a 23% reduction in the cancer death rate in the United States, saving nearly 2 million lives,1 cancer remains the second leading cause of death after heart...
FDA Approves Osimertinib Blood-Based T790M Companion Diagnostic Test
On September 29, the U.S. Food and Drug Administration (FDA) approved a blood-based companion diagnostic for osimertinib (Tagrisso). The companion diagnostic for osimertinib is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample ...
FDA Approves Blinatumomab for Use in Pediatric Patients With Ph-Negative Relapsed or Refractory B-Cell Precursor ALL
The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome (Ph)-negative relapsed or refractory B-cell precursor acute...
FDA Takes Action Against 55 Tobacco Retailers for Selling Newly Regulated Products to Minors
The U.S. Food and Drug Administration (FDA) announced on September 15 that it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products—such as e-cigarettes, e-liquids, and cigars—to minors. These actions come about a month after ...
FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small cell lung cancer...
FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which...
Enhanced Survival With Implantable Scaffolds That Capture Metastatic Breast Cancer Cells in Vivo
A small device implanted under the skin may improve breast cancer survival by catching cancer cells, slowing the development of metastatic tumors in other organs, and allowing time to intervene with surgery or other therapies. These findings, reported by Rao et al in Cancer Research, suggest a path ...
Reducing Drug Costs by Increasing Science-Driven Drug Discovery
For several years now, the American health-care system has been undergoing a transformation. Innovative ideas are being explored, new systems continue to be created, and millions of lives have been impacted. As health-care providers and research engines, academic institutions have an opportunity...
ASCO and AACI Initiative to Reduce Administrative and Regulatory Burden in Cancer Clinical Trials
As reported in the Journal of Clinical Oncology, Julie M. Vose, MD, MBA, FASCO, of the University of Nebraska Medical Center, Omaha, and colleagues have provided a summary of the groundwork of an initiative by ASCO and the Association of American Cancer Institutes (AACI) to identify and reduce...
Vice President Biden Announces New Steps to Improve Clinical Trials Essential to Advancing the Cancer Moonshot
Today, Vice President Joe Biden announced a series of new steps focused on increasing access to information about clinical trials and improving the efficiency of our clinical research system. These steps include making it easier for participants to find clinical trial opportunities as quickly as...
American Association for Cancer Research Releases 2016 Cancer Progress Report
Federally funded research continues to spur progress against cancer; however, accelerating the pace of progress will require robust, sustained, and predictable annual funding increases for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Food and Drug...
FDA Modifies Dosage Regimen for Nivolumab
On September 13, 2016, the U.S. Food and Drug Administration (FDA) modified the dosage regimen for nivolumab (Opdivo) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer (NSCLC). The currently approved recommended dosage...
FDA Warns of Risks Associated With the Use of Tests Marketed as ‘Ovarian Screening’
The U.S. Food and Drug Administration (FDA) is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The agency is especially concerned about delaying effective preventive treatments for women who show no symptoms but who are still at...
ASCO and AACI Collaborate on Initiative to Reduce Administrative and Regulatory Burden in Cancer Clinical Trials
As reported in the Journal of Clinical Oncology, Vose et al have provided a summary of the groundwork of an initiative by ASCO and the Association of American Cancer Institutes (AACI) to identify and reduce administrative and regulatory burdens in the conduct of cancer clinical trials. The...
Media Reports of Dramatic Responses to Immunotherapy After All Else Fails May Prompt Patients to Seek It Out
Immunotherapy has received “a lot of attention, mainly because of the media coverage,” Anas Younes, MD, medical oncologist and Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center in New York, said in an interview with The ASCO Post. “Many patients inquire, not about a specific...
FDA Grants Priority Review to Pembrolizumab for First-Line Treatment of Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small...
ASCO 2016: Geriatric Oncology Highlights
Clinical trials focused on older adults with cancer were featured prominently at the 2016 ASCO Annual Meeting. There was a plenary session in glioblastoma, a clinical symposium on immunotherapy, and multiple educational lectures highlighting the growing literature and unique challenges in the...
FDA Grants Orphan Drug Designation to CD4CAR for the Treatment of Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for chimeric antigen receptor–engineered T cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma. William Tse, MD, Chief of the Blood and Marrow Transplantation Division ...
FDA Approves Blinatumomab for Use in Pediatric Patients With Ph-Negative Relapsed or Refractory B-Cell Precursor ALL
The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome (Ph)-negative relapsed or refractory B-cell precursor acute...
Early Relapse in Follicular Lymphoma: Clinical Trial Data May Guide Management Decisions
Approximately 20% of patients with follicular lymphoma will relapse within 2 years of diagnosis. Although the optimal management of these patients has not been established, clinicians may be guided by data from recent clinical trials, according to Nathan H. Fowler, MD, Associate Professor and...
