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Showing 2451 - 2500The 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...
FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
Genmab A/S announced today that 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...
Researchers Question Process for Reviewing Coverage of 'Off-Label' Cancer Drug Use
A group of University of North Carolina (UNC) Lineberger Comprehensive Cancer Center researchers is calling for an overhaul of the process that determines which cancer drugs used off-label—or beyond their approved use—are reimbursed by federally funded health insurance in the United...
FDA Accepts New Drug Application, Grants Priority Review of Rucaparib for the Treatment of Advanced BRCA-Mutant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Clovis Oncology’s New Drug Application (NDA) for accelerated approval of rucaparib and granted Priority Review status to the application with a Prescription Drug User Fee Act date of February 23, 2017. Rucaparib is an...
Former Clinical Director at the NCI, Gregory A. Curt, MD, Dies
In MemoriamGregory A. Curt, MD1952 – 2016 Gregory A. Curt, MD, Former Clinical Director at the National Cancer Institute (NCI) and nationally regarded expert on translational oncology died on July 31, 2016. He was 64 years old. Dr. Curt received his MD with distinction in research from the...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) has approved an extended-release version of granisetron (Sustol) for the prevention of chemotherapy-induced nausea and vomiting, according to a news release by Heron Therapeutics, the drug’s manufacturer. Granisetron is an extended-release, injectable...
FDA Approves Pembrolizumab for Metastatic Head and Neck Squamous Cell Carcinoma
On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or ...
GADOLIN and the Perplexing Role of Obinutuzumab in the Treatment of B-Cell Malignancies
After several dose-finding phase I and II studies in a variety of B-cell malignancies, the potential clinical role of the newer anti-CD20 monoclonal antibody obinutuzumab (Gazyva) remained unclear. These early trials tested low and high doses as well as weekly and every-3-week schedules of...
Scalp Cooling for Chemotherapy-Induced Alopecia Becoming Mainstream
Hair loss can be a devastating side effect of chemotherapy, but the recent U.S. Food and Drug Administration (FDA) approval of the DigniCap Cooling System and the growing acceptance of scalp-cooling methods in the United States may improve the quality of life for many patients receiving...
ASCO Guideline Addresses Controversial Areas in Adjuvant Therapy for Breast Cancer
ASCO has published an adaptation of the 2015 Cancer Care Ontario (CCO) clinical practice guideline on adjuvant chemotherapy for early-stage breast cancer.1 There were several areas of controversy that the guideline attempts to address. Should Anthracyclines Be Standard of Care? The guideline...
How the Oncology Center of Excellence Plans to Foster Collaboration Among Researchers to Advance Cancer Treatment
On June 29, 2016, Robert M. Califf, MD, MACC, the Commissioner of the U.S. Food and Drug Administration (FDA), announced the selection of Richard Pazdur, MD, FACP, as Acting Director of the FDA’s newly created Oncology Center of Excellence. The center was created in response to the overarching...
Inotuzumab Ozogamicin Shows Clear Benefit in Acute Lymphoblastic Leukemia
In patients with relapsed/refractory acute lymphoblastic leukemia (ALL), the antibody-drug conjugate inotuzumab ozogamicin produced significantly more complete remissions and was a better bridge to transplant than treatment by physician’s choice, according to the final results of a phase III trial...
FDA Grants Orphan Drug Designation to CD4CAR for the Treatment of Peripheral T-Cell Lymphoma
iCell Gene Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma (PTCL). William Tse, MD,...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron (Sustol) extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention ...
Multiple Means to Realize the Benefits of Colorectal Cancer Screening
In an updated recommendation statement, the U.S. Preventive Services Task Force (USPSTF) continues to strongly recommend screening for colorectal cancer for asymptomatic adults aged 50 through 75; but rather than emphasize specific screening strategies, it notes there are multiple screening...
FDA Approves Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Chemotherapy
The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, at a fixed dose of 200 mg every 3 weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with...
Reference Laboratory Identifies Change in Pattern of Breast Cancer HER2 Fluorescence in Situ Hybridization Results
The most recent (2013) ASCO/College of American Pathologists (AC) guidelines for HER2 testing resulted in different rates of HER2 positivity compared with the use of the U.S. Food and Drug Administration (FDA) or 2007 AC guidelines, according to a study reported in the Journal of Clinical Oncology...
FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection
The U.S. Food and Drug Administration (FDA) approved Epclusa (sofosbuvir at 400 mg/velpatasvir at 100 mg) on June 28, 2016, to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis),...
FDA Approves First HPV Test for Use With SurePath Preservative Fluid
On July 7, 2016, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for human papillomavirus (HPV) that can be used with cervical cells obtained for a Papanicolau (Pap) test and collected in SurePath Preservative Fluid. The FDA approves HPV tests to be...
Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial After FDA Clinical Hold
Juno Therapeutics, Inc., announced on July 12, 2016, that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the phase II clinical trial of JCAR015 (known as the ROCKET trial; clinicaltrials.gov identifier NCT02535364) in adult patients with relapsed or refractory B-cell...
Ribociclib Receives FDA Breakthrough Therapy Designation for Treatment of Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib in combination with letrozole for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib...
ASCO and Friends of Cancer Research Launch Initiative to Modernize Eligibility Criteria for Clinical Trials
The dismal accrual rates in cancer clinical trials are well known: Just 3% to 5% of adults with cancer enroll in clinical trials.1 The reasons patients are reluctant to participate in clinical trials are equally well known: fear of reduced quality of life, concern about receiving a placebo, and...
FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have ...
The National Cancer Moonshot Lifts Off
Just 6 months after President Barack Obama announced the establishment of a National Cancer Moonshot Initiative to accelerate the pace of research discoveries, improve patient access and care, and encourage data-sharing, dozens of new initiatives to accomplish those and other goals were rolled out...
FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests
In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances. When finalized, they will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s...
As Low-Dose CT Screening Moves Into the Clinic, Implementation Issues Move Up on the Agenda
Low-dose computed tomography (CT) screening for lung cancer in high-risk groups is moving into the clinic in the wake of its approval by the U.S. Centers for Medicaid & Medicare Services. That does not mean, however, the discussion is over. As low-dose CT moves from research to everyday...
