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Showing 2201 - 2250FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 Approval was based on a 154-patient subgroup of...
Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR)...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...
FDA Recent Approvals Include First Oncology Biosimilar
ON SEPTEMBER 14, 2017, the U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the United States for the treatment of cancer....
Small Steps Forward in Brain Tumor Therapy
SOME RECENT ADVANCES in the treatment of brain tumors are promising, but others are less so, according to Jeffrey J. Olson, MD, Professor of Neurosurgery at Emory University, Atlanta. At the 2017 Debates and Didactics in Hematology and Oncology Conference, held in Sea Island, Georgia, and...
PD-L1 Inhibitor Consolidation Therapy for NSCLC: New Standard of Care?
THE PROGRAMMED CELL DEATH ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) improved progression-free survival by 11.2 months compared with placebo in patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) whose disease did not progress following standard treatment ...
Adoptive Cell Therapy—Act 1: The Beginning
ON AUGUST 30, 2017, the first genetically engineered T-cell therapy (tisagenlecleucel [Kymriah]) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or...
AACR Releases 2017 Cancer Progress Report: Harnessing Research Discoveries to Save Lives
Federally funded research that provides a deep understanding of cancer is spurring advances against many types of the disease. With a strong bipartisan commitment from Congress to keep investment in biomedical research a national priority, we can accelerate our pace of progress and save more lives...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
FDA Approves First Biosimilar for the Treatment of Cancer
The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to...
FDA Pilot Program Aims to Encourage Students to Pursue STEM Careers
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet it is precisely those students who...
‘Substantial Improvements’ in the Treatment of Glioblastoma
NEWS ARTICLES about Senator John McCain’s diagnosis of glioblastoma accurately describe glioblastoma as aggressive and having a poor prognosis. But as Walter J. Curran, Jr, MD, pointed out in one of those reports, “substantial improvements in surgical approaches” have enabled more patients to...
Expert Point of View: David Maloney, MD, and Kenneth C. Anderson, MD
SIMILAR CELLULAR immunotherapies are currently being developed and tested by other National Cancer Institute–designated cancer centers, including Fred Hutchinson Cancer Research Center. David Maloney, MD, Medical Director of Cellular Immunotherapy at Fred Hutchinson and Medical Director of the...
FDA Approves First CAR T-Cell Therapy for Pediatric, Young Adult Patients With ALL
ON AUGUST 30, 2017, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for pediatric and young adult patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory to initial treatment or in second or later relapse. Tisagenlecleucel ...
FDA Approves Betrixaban for Prophylaxis of Venous Thromboembolism
ON JUNE 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Register for the Geriatric Oncology Workshop
On November 6, 2017, ASCO and the U.S. Food and Drug Administration (FDA) will hold a joint Geriatric Oncology Workshop aimed at improving the evidence base for treating the geriatric oncology population. While more than 60% of cancers in the United States occur in people aged 65 and older, the...
FDA Announces New Comprehensive Plan for Tobacco and Nicotine Regulation
Recently, the U.S. Food and Drug Administration (FDA) announced a new strategy to address tobacco-related disease and death. The agency seeks to develop a plan to reduce the nicotine levels in combustible cigarettes to nonaddictive levels. However, as part of the strategy, the FDA also announced it ...
Emerging Global Leaders in Biosimilar Development: Regulatory Guidance and Cost Impact
BIOLOGICS PLAY A KEY ROLE in cancer treatment and are the principal components of many therapeutic regimens.1 However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply, limiting the accessibility of cancer treatment for many patients, more so ...
Positioning Lu-177 Dotatate Therapy and 68-Ga Dotatate Scans in Management of Neuroendocrine Tumors
The results of the phase III NETTER-1 trial, recently published in The New England Journal of Medicine,1 have been met with great interest by clinicians who treat neuroendocrine tumors. In patients with advanced midgut lesions, treatment with the radiopharmaceutical lutetium Lu-177 dotatate...
Recent FDA Actions Include New Formulation, Expanded Indications for Oncology-Hematology Drug Products
The U.S. Food and Drug Administration (FDA) recently granted approval to olaparib tablets (Lynparza) as a maintenance therapy for ovarian cancer and to inotuzumab ozogamicin (Besponsa), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)....
FDA Clears Mammography Device With Option for Patient-Assisted Compression
On September 1, the U.S. Food and Drug Administration (FDA) cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. “Regular mammograms are an important tool in...
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma
On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...
FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL
Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...
FDA Grants Breakthrough Therapy Designation to DS-8201 for HER2-Positive Metastatic Breast Cancer
On August 29, Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody-drug conjugate, for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer...
FDA Accepts sBLA, Grants Priority Review for Obinutuzumab in Previously Untreated Follicular Lymphoma
On August 28, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for obinutuzumab (Gazyva) in combination with chemotherapy followed by obinutuzumab alone for patients with previously untreated follicular lymphoma....
FDA Approves Fulvestrant as Monotherapy for Expanded Use in Breast Cancer
On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause...
Reagan-Udall Foundation for the FDA Launches Expanded Access Navigator Website
THE NONPROFIT Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has released a new online resource called the Expanded Access Navigator. The website, which focuses on oncology, features the first pharmaceutical company directory of expanded access policies and criteria, as...
Pursuing Combination Strategies With Checkpoint and Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma
PRIMARY LIVER CANCER is the second leading cause of cancer-related death worldwide. Hepatocellular carcinoma accounts for 90% of liver cancer, with around 800,000 new cases diagnosed globally each year.1 In contrast to the stable or declining trends observed for most neoplasms, the incidence and...
New ASCO Recommendations for Controlling Nausea and Vomiting Related to Cancer Treatment
AN UPDATE of the ASCO Clinical Practice Guideline covers new medicines for nausea and vomiting related to cancer treatment. The update, issued by Hesketh et al in the Journal of Clinical Oncology,1 provides new evidence-based information on the appropriate use of olanzapine, neurokinin 1 (NK1)...
International Consensus (or Not) on Management of Advanced Prostate Cancer
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
Fighting Misinformation in HPV-Related Cancer Prevention
FAKE NEWS, junk science, and alternative facts seem pervasive in our current culture, to the detriment of important, verified scientific advancements. One area where this is quite evident is the vaccine against human papillomavirus (HPV). Although we have had a safe, effective vaccine since 2006...
FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to...
FDA Approves Inotuzumab Ozogamicin for Relapsed or Refractory B-Cell Precursor ALL
On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). INO-VATE ALL The approval was based on data from INO-VATE ALL, a randomized (1:1), ...
Look for Opportunities to Lower Barriers to Participation of Older Patients in Oncology Clinical Trials
Practicing evidence-based medicine requires evidence, but the evidence for efficacy and safety of new and evolving cancer therapies in older adults is wanting due to their underrepresentation in oncology clinical trials. “It is difficult to practice evidence-based medicine in an older population...
‘Slow, Incremental Changes’ Are Increasing Participation of Older Adults in Clinical Trials
Older adults continue to be proportionally underrepresented in oncology clinical trials, but the participation rate of adults aged 65 and older is increasing by “slow, incremental changes,” Stuart M. Lichtman, MD, FACP, FASCO, noted in an interview with The ASCO Post. Prompting those changes are...
FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
Recent FDA Actions Include New Drug Approvals in Leukemia, Expanded Approvals in Colorectal Cancer and Graft-vs-Host Disease
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Triple-Negative Breast Cancer: Practical Approach, Promising Research
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use
On August 8, the U.S. Food and Drug Administration (FDA) announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by children. The agency plans to expand its “The Real...
Senate Passes the RACE for Children Act
On August 3, the leadership of Kids v Cancer, an advocacy group promoting pediatric cancer research, issued the following statement: Today, the U.S. Senate passed the FDA Reauthorization Act and with it, the RACE for Children Act. Now, new cancer drugs will be developed not only for...
ASCO Tackles the Issue of the High Cost of Cancer Drugs
In July, ASCO issued a comprehensive set of recommendations to remedy the problem of escalating drug pricing on cancer therapies.1 ASCO’s position statement comes at a time when new cancer drugs are routinely priced at $100,000 a year or more—imatinib (Gleevec) costs up to $146,000 a year2—causing...
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Some Types of Poor-Prognosis AML
On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related...
FDA Grants Alectinib Priority Review for Initial Treatment of ALK-Positive Lung Cancer
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death
On July 28, the U.S. Food and Drug Administration (FDA) announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multiyear roadmap to better protect children and significantly reduce tobacco-related disease and death. The approach places nicotine and the issue of...
