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Showing 1301 - 1350Clinical Trials to Evaluate Activity of Biologics, Other Agents Against COVID-19
In an effort to expedite research for agents with potential activity against symptoms associated with the novel coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) is evaluating and/or has approved a number of randomized clinical trials seeking to determine whether a drug has...
FDA Approves Luspatercept-aamt for Second-Line Treatment of Anemia in Adult Patients With Myelodysplastic Syndromes
On April 3, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia that fails to respond to an erythropoiesis-stimulating agent and requires two or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk...
FDA Pipeline: Approval of New Dosing for Biosimilar, Plus Two Fast Track Designations
The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma. Approval of Multidose Vial of Trastuzumab Biosimilar The FDA approved a...
Maintaining Blood Donations During the COVID-19 Pandemic
A major casualty of the coronavirus disease 2019 (COVID-19) pandemic is the dramatic decrease in the number of blood donations across the United States. As more people are urged to shelter-in-place and avoid social contact, the number of cancellations in blood drives has been dramatic. According to ...
FDA Approves Durvalumab as Part of a First-Line Combination Regimen for Extensive-Stage SCLC
On March 27, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). CASPIAN Trial Efficacy of this combination in patients...
Neratinib Combined With Capecitabine in Previously Treated Advanced HER2-Positive Breast Cancer
On February 25, 2020, neratinib (Nerlynx) was approved for use in combination with capecitabine for treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2 Supporting Efficacy ...
A Message From the FDA OCE for Patients With Cancer and Health-Care Providers on COVID-19
On March 23, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued the following statement: The FDA OCE recognizes that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease (COVID-19). While everyone’s daily lives...
TAPUR Basket Study: Biomarker-Driven Treatment Strategies Yield Benefits in Colorectal Cancer
Positive findings on the potential benefit of molecularly targeted drugs in patients with advanced colorectal cancer were presented at the 2020 Gastrointestinal Cancers Symposium, validating the purpose of ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study.1-3 TAPUR, the first...
Coronavirus, Patients With Cancer, and the Preparedness of the Institutions That Care for Them
We're covering the topic on everyone’s minds—coronavirus. We’ll start with the state of the epidemic as it relates to patients with cancer and the preparedness of the institutions that care for them. Next, we’ll look at a study from China that examined the impact of COVID-19 on patients with...
Continuous Coverage of COVID-19
The staff of The ASCO Post recognizes the steady flow of news on the novel coronavirus, or COVID-19. Here, we've compiled a list of links to articles and resources on the COVID-19 pandemic. If you have a report you'd like to share, please e-mail it to us at editor@ascopost.com. Direct From ASCO:...
Mitigating the Spread of COVID-19 and Its Impact on Cancer
On March 11, the World Health Organization (WHO) took the step it had been avoiding for weeks and declared that the spread of the coronavirus disease 2019 (COVID-19), and the virus that causes it, now identified as SARS-CoV-2, had reached global pandemic levels, the first pandemic sparked by a...
FDA Pipeline: Breakthrough Therapy for NSCLC With Specific Mutation, Approval of Test for Cervical Cancer, and More
Over the past week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to a bispecific antibody for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations; granted approval to a test for human...
HAPLO2019: Advances in Haploidentical Transplantation and Other Novel Cellular Therapies
Now in its seventh year, the Haploidentical Transplant Symposium (HAPLO) continues to explore advances in haploidentical and other novel cellular therapies. The most recent of these meetings—HAPLO2019—met in Orlando, Florida, 2 days before the start of the 2019 American Society of Hematology (ASH)...
FDA Approves Nivolumab/Ipilimumab for Pretreated Patients With Hepatocellular Carcinoma
On March 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib. CheckMate 040 Efficacy of the combination was...
Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of...
Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation
On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...
Expert Point of View: James N. Gerson, MD
James N. Gerson, MD, Assistant Professor of Medicine at Perelman School of Medicine, University of Pennsylvania, Philadelphia, commented on the implications of the findings from CAPTIVATE. “Upfront therapy for chronic lymphocytic leukemia (CLL) is rapidly evolving. We now have three...
Acalabrutinib Plus Obinutuzumab Superior to Obinutuzumab Plus Chlorambucil as Front-Line Treatment of CLL
Ibrutinib was the first Bruton’s tyrosine kinase (BTK) inhibitor to dramatically transform the treatment of patients with chronic lymphocytic leukemia (CLL) and other hematologic malignancies. The second-generation BTK inhibitor acalabrutinib is a more selective BTK inhibitor designed to have an...
PD-L1 Expression Testing
Vamsi Velcheti, MD, and David Rimm, MD, PhD, discuss the high number of recent programmed death ligand 1 (PD-L1) inhibitor approvals and the need to harmonize the various diagnostic assay developments across the supporting clinical trials. Dr. Rimm notes the important difference between companion...
Expert on Public Health and Policy Looks at Precision Oncology
A study published in JAMA Oncology found that 31 genome-targeted anticancer agents were in use as of January 2018.1 To shed light on the current state of precision oncology, The ASCO Post recently spoke with David M. Cutler, PhD, the Otto Eckstein Professor of Applied Economics in the Department of ...
FDA Pipeline: Priority Review in DLBCL, Fast Track Designations in T-Cell Lymphoma and Adenoid Cystic Carcinoma
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a combination therapy in diffuse large B-cell lymphoma (DLBCL); gave Fast Track designations for treatments in T-cell lymphoma and adenoid cystic carcinoma; granted Orphan Drug designation to an agent for the ...
Former FDA Commissioner Scott Gottlieb, MD, Relays Opinions on Coronavirus
Scott Gottlieb, MD, former Commissioner of the U.S. Food and Drug Administration (FDA), had some advice for attendees of the 37th Annual Miami Breast Cancer Conference in his keynote address at the meeting. While his formal presentation pertained to innovations in oncology drug development and...
Adding Capecitabine to Systemic Therapies Improves Outcomes in Triple-Negative Breast Cancer
Capecitabine improves disease-free and overall survival for patients with triple-negative breast cancer, but only when it is added to other systemic therapies, not when it is used as a substitute, according to a large meta-analysis of the effects of capecitabine in early breast cancer, The results...
Phase III HER2CLIMB Trial Yields Positive Data in Patients With HER2-Positive Metastatic Breast Cancer and Brain Metastasis
The investigational oral agent tucatinib added to trastuzumab/capecitabine reduced the risk of death by one-third and reduced the risk of disease progression or death by one-half in patients with heavily pretreated metastatic HER2-positive breast cancer, including those with untreated or previously ...
Conference Highlights From the 2019 San Antonio Breast Cancer Symposium
More than 7,500 specialists in breast oncology from over 90 countries attended the 2019 San Antonio Breast Cancer Symposium (SABCS) held last December. Researchers convened to present a wide-ranging array of abstracts and posters featuring important new data in the treatment of breast cancer....
Phenelzine for Biochemical Recurrent Castration-Sensitive Prostate Cancer
A monoamine oxidase A (MAOA) inhibitor in use for decades as an antidepressant demonstrated activity in patients with recurrent prostate cancer, with most toxicities seen with the treatment being reported as mild. These findings were published by Gross et al in Prostate Cancer and Prostatic...
FDA Approves Isatuximab-irfc–Based Triplet Regimen for Patients With Relapsed or Refractory Multiple Myeloma
On March 2, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. ...
New Guideline Tackles Rapidly Evolving Imaging Strategies for Advanced Prostate Cancer
Advances in radiology and molecular imaging have the potential to significantly change how clinicians diagnose, stage, and monitor response to therapy in patients with prostate cancer. However, there are limited data comparing these next-generation imaging modalities to each other and to...
Two Recent Studies Show Low-Nicotine Cigarettes Are Unlikely to Increase Compensatory Smoking
A pair of studies by Smith et al published in Cancer Epidemiology, Biomarkers & Prevention evaluating whether a mandated reduction in the nicotine content of cigarettes may cause smokers to compensate by engaging in compensatory smoking to obtain more nicotine has found that a reduction in...
FDA Pipeline: Priority Review in Lung Cancer, Breakthrough Therapy Designation in Head and Neck Cancer, and More
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to brigatinib for the treatment of ALK-positive lung cancer and Breakthrough Therapy designation to a potential first-in-class oral antagonist of inhibitors of apoptosis proteins for the treatment of head and neck...
FDA Approves Neratinib/Capecitabine for Pretreated Patients With Metastatic HER2-Positive Breast Cancer
On February 25, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlynx), a tyrosine kinase inhibitor, in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the...
Preliminary Study Finds ASCO Decision Aid May Improve Quality of Serious Adverse Events Reporting
Sponsors of clinical trials conducted under investigational new drug applications are required by the U.S. Food and Drug Administration (FDA) to report serious adverse events that are unexpected and suspected to be related to the drug. However, contrary to FDA guidance, investigators often send...
Update on Project Facilitate at the Oncology Center of Excellence
OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...
Pembrolizumab Plus Chemotherapy in HER2-Negative Breast Cancer
We’ll start off by discussing results from the I-SPY 2 trial on the efficacy of pembrolizumab plus chemotherapy in HER2-negative breast cancer. Then, we’ll move on to a report covering racial disparities in diagnostic and treatment technology as related to outcomes in patients with colorectal...
New ASCO Guideline Highlights Need to Improve Germline, Somatic Tumor Testing in Epithelial Ovarian Cancer
A new ASCO clinical practice guideline provides clinicians and other health-care professionals with evidence-based recommendations on genetic and tumor testing for women diagnosed with epithelial ovarian cancer.1 “We wanted to go over the evidence and make strong statements and recommendations...
FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...
Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer
On January 8, 2020, pembrolizumab was approved for treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2...
Pivotal Trial Evaluates Second-Generation BTK Inhibitor Alone and in Combination With Obinutuzumab for First-Line Treatment of CLL
The second-generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, alone, or in combination with obinutuzumab significantly improved progression-free survival compared with a standard combination of obinutuzumab/chlorambucil in treatment-naive patients with chronic lympocytic leukemia...
Early Data Suggest Efficacy of Innovative CAR NK-Cell Therapy for B-Cell Malignancies
FT596, a novel off-the-shelf chimeric antigen receptor natural killer cell (CAR-NK) product, was as effective as existing CAR T-cell platforms in killing cancer cells in vivo, and the combination of FT596 plus rituximab killed lymphoma cancer cells that were no longer responding to CAR T-cell...
Will Bispecific Antibodies Compete With CAR T-Cell Therapy in Lymphoma?
Are second-generation bispecific antibodies the next big thing in lymphoma? Studies of these drugs were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. Years ago, the bispecific T-cell engager blinatumomab validated the concept of bispecific...
Conference Highlights From the 2019 American Society of Hematology Annual Meeting & Exposition
More than 25,000 specialists in hematology from over 115 countries attended the 61st American Society of Hematology (ASH) Annual Meeting & Exposition held last December in Orlando. The conference featured a stunning array of 4,900 abstracts with impressive new data in the treatment of multiple...
FDA Pipeline: Priority Reviews in Lymphoma, Lung Cancer, GIST, and Breast Cancer
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents in lymphoma, lung cancer, gastrointestinal stromal tumors, and breast cancer, and granted Fast Track designation to a first-in-class radioenhancer hafnium oxide nanoparticle in head and neck cancer. Priority...
Congress Increases Federal Investment in Cancer Research, Raises Tobacco Purchasing Age
President Trump recently signed a bill that funds the federal government, including the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the U.S. Food and Drug Administration (FDA), for Fiscal Year (FY) 2020. Importantly, the bill also raises the purchasing age of...
Genomics-Guided Molecular Targeted Therapy Gave Me Back My Life
In October 2014, I noticed a small pea-sized lump on the left side of my cheek. It didn’t hurt, and I didn’t have any physical symptoms that could connect the lump with a rare and serious disease, but I was curious enough about what the lump could be to get it checked out by my primary care...
Comparing Prescribing Habits in Academic and Nonacademic Oncology Settings
The art of oncology practice is tailored to the individual patient with cancer, and with the advent of highly personalized targeted therapies, patient outcomes have improved markedly over the past several decades. Although much of oncology practice is guideline- or protocol-driven, chemotherapy...
CAR T-Cell Gene Therapy in Non-Hodgkin Lymphomas: Present and Future
To complement The ASCO Post’s continued comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel immunotherapies for patients with different types of non-Hodgkin...
FDA Pipeline: Priority Review Granted for Treatment in Lung and Thyroid Cancers
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a treatment for lung and thyroid cancers with a RET fusion or mutation; gave Breakthrough Therapy designation to a doublet therapy for TP53-mutated myelodysplastic syndromes; and issued an update to their...
News From the Gastrointestinal Cancers Symposium
The 2020 Gastrointestinal Cancers Symposium took place last weekend, and this week, we’ll take a deeper dive into findings in pancreatic cancer and colorectal cancer. We’ll also review the FDA approval of tazemetostat in epithelioid sarcoma.
When Added to Other Systemic Therapies, Capecitabine Improves Outcomes in Triple-Negative Breast Cancer
Capecitabine is often used to treat breast cancer, but the best use of capecitabine is open for discussion. According to a large meta-analysis of the effects of capecitabine in early breast cancer, capecitabine improves disease-free and overall survival for patients with triple-negative breast...
CAR T-Cell Therapy Comes to Mantle Cell Lymphoma
Advanced mantle cell lymphoma appears to be a good target for chimeric antigen receptor (CAR) T-cell therapy. Treatment with KTE-X19, an anti-CD19 CAR T-cell product, led to unprecedented outcomes in patients with relapsed or refractory disease in the phase II ZUMA-2 study presented at the 2019 ASH ...
