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Showing 1301 - 1350Conference 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 ...
FDA Pipeline: Priority Reviews in Multiple Myeloma, Prostate Cancer
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for multiple myeloma and prostate cancer; gave Fast Track designation to a targeted gene therapy for lung cancer; granted Orphan Drug designation to a combination therapy for hepatocellular...
Surgeon General Releases Report Focused on Smoking Cessation
Three decades after the first Surgeon General's report on smoking cessation, the Surgeon General has released a new report that reviews and updates evidence on the importance of quitting smoking. The report finds that more than two-thirds of U.S. adult cigarette smokers report an interest in...
FDA Approves Tazemetostat for Epithelioid Sarcoma
On January 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. “Epithelioid sarcoma accounts...
Olaparib as Maintenance Therapy for Germline BRCA-Mutated Metastatic Pancreatic Adenocarcinoma
On December 27, 2019, the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib was approved for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma, as detected by a U.S. Food and Drug Administration...
Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer
On December 18, 2019, the antibody-drug conjugate enfortumab vedotin-ejfv (PadcevTM) was granted accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed cell...
Fam-trastuzumab Deruxtecan-nxki for Previously Treated Unresectable or Metastatic HER2-Positive Breast Cancer
On December 20, 2019, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was granted accelerated approval in the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2...
Atezolizumab With Chemotherapy for Metastatic Nonsquamous NSCLC Without EGFR/ALK Aberrations
On December 3, 2019, atezolizumab in combination with nab-paclitaxel and carboplatin was approved for first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumore aberrations.1,2 The approval was based on findings in the open-label phase III...
FDA Grants Breakthrough Therapy Designation to Tucatinib in Combination Therapy for HER2-Positive Breast Cancer
Seattle Genetics recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast...
Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
On December 16, 2019, enzalutamide (Xtandi) was approved for the treatment of patients with metastatic castration-sensitive prostate cancer.1,2 Supporting Efficacy Data The current approval was based on findings from the phase III double-blind ARCHES trial (ClinicalTrials.gov identifier...
FDA’s Pilot Project Patient Voice Website and Workshop With ASCO
Project Patient Voice (PPV) is a program that will gather and make available online, patient-reported outcomes from cancer clinical trials. Launched by the U.S. Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE), it is the first program of its kind to communicate...
Value-Based and Patient-Centered Cancer Care: Looking at Closing Gaps in Perspectives of Value
Value-based care in oncology—a concept that emphasizes quality over quantity—has evolved over the past 2 decades to become a guiding principle of both public and private payers. The concept was part of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008; informed elements of...
Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes
We’ll start off this week by discussing results from the MEDALIST trial of luspatercept in transfusion-dependent lower-risk myelodysplastic syndromes. Then, we’ll move to a study that’s been covered a lot in the news: does the use of powder in the genital area increase a woman’s chance of ovarian...
FDA Pipeline: Priority Reviews in Ovarian Cancer, Prostate Cancer, and NSCLC
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for ovarian, prostate, and lung cancer; granted Orphan Drug designation to therapies for chemotherapy-induced thrombocytopenia and multiple myeloma; and granted Breakthrough Device designation to platforms...
Recent Approvals From the FDA
The U.S. Food and Drug Administration (FDA) certainly had a busy December, and this week, we’ll be reviewing some recent approvals: olaparib for germline BRCA-mutated metastatic pancreatic cancer; fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive breast...
FDA Pipeline: Fast Track/Orphan Drug Designation for Cholangiocarcinoma Treatment, Breakthrough Device Designation for Bladder Cancer Test
This week, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to infigratinib for patients with advanced or metastatic cholangiocarcinoma with a certain genetic mutation, and Orphan Drug designation to the treatment for patients with cholangiocarcinoma. The FDA also granted...
FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor
On January 9, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbors platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes...
Preliminary Data on Multiantigen-Targeted CAR NK-Cell Therapy for B-Cell Malignancies
A novel off-the-shelf chimeric antigen receptor natural killer cell (CAR-NK) product called FT596 may prove to be an active therapy for B-cell malignancies. This agent is designed to overcome several challenges inherent in CAR T-cell therapy, including CD19-antigen escape, which leads to relapse in ...
FDA Approves PD-1 Inhibitor for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the 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...
FDA Pooled Analysis of CDK4/6 Inhibitor Treatment for Advanced Hormone Receptor–Positive, HER2-Negative Breast Cancer
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Jennifer J. Gao, MD, and colleagues found that the magnitude of progression-free survival benefit with the addition of a cyclin-dependent kinase (CDK) 4/6 inhibitor to endocrine therapy in women with...
JAVELIN Bladder 100 Study of Avelumab for Urothelial Cancer Meets Primary Endpoint
The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...
FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes
Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration (FDA) has issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to children, including fruit...
FDA Approves Olaparib for Patients With Germline BRCA-Mutated Metastatic Pancreatic Cancer
On December 27, 2019, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) as a maintenance treatment for adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma as detected by an FDA-approved test whose disease has not ...
Preliminary Study Finds ASCO Decision Aid May Improve Quality of Serious Adverse Events Reporting
Sponsors of clinical trials conducted under investigational new drug (IND) 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...
Highlights From the 2019 ASCO Research Community Forum Annual Meeting
Researchers from around the country joined together for learning and collaboration at the 2019 ASCO Research Community Forum (RCF) Annual Meeting in September. During the meeting, Aisha Peterson Johnson, MD, MPH, MBA, of the U.S. Food and Drug Administration (FDA) Office of Compliance, delivered a...
