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Showing 1351 - 1400CAR 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...
Trastuzumab and Hyaluronidase-oysk for Subcutaneous Use in HER2-Positive Breast Cancer
Early in 2019, trastuzumab and the endoglycosidase hyaluronidase-oysk for subcutaneous injection was approved in the treatment of HER2-positive breast cancer.1,2 The agent is indicated for adjuvant treatment of patients with HER2-overexpressing node-positive or node-negative (estrogen...
Rituximab-abbs: Biosimilar to Rituximab for Non-Hodgkin Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Late in 2018, rituximab-abbs was approved as the first...
My Dream Is That Multiple Myeloma Will One Day Be in My Past and No Longer a Part of My Future
A year before my diagnosis of multiple myeloma, in 2010, my husband Paul and I moved with our six children to Monterrey, Mexico, where Paul was helping to create a venture capital industry. We were so busy settling into a new country and getting our children integrated into school that when I...
FDA Pipeline: Priority Reviews in SCLC, Bladder Cancer, Colorectal Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Patients With Unresectable or Metastatic HER2-Positive Breast Cancer
On December 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting....
Companion Diagnostic Approved for Alpelisib/Fulvestrant Therapy
On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal women as well as male patients with hormone receptor–positive, HER2-negative, PIK3CA-mutated,...
Gilteritinib for Relapsed or Refractory AML With FLT3 Mutation
Late in 2018, the FLT3 inhibitor gilteritinib was approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved an expanded indication...
Selected Abstracts From the 2019 ASH Annual Meeting & Exposition
To complement The ASCO Post’s 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 therapeutic regimens for acute myeloid leukemia (AML). For full details of these...
Pembrolizumab in Adjuvant Treatment of Melanoma With Involvement of Lymph Nodes After Complete Resection
In early 2019, pembrolizumab was approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind EORTC 1325/KEYNOTE-054 trial (ClinicalTrials.gov identifier...
Acalabrutinib for Adult Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
On November 21, 2019, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib was approved for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The review resulting in approval was conducted under Project Orbis, an initiative of the U.S....
ASCO’s National Cancer Opinion Survey Finds Gaps in Knowledge on Cancer Prevention and the Dangers of E-Cigarettes
As in the previous 2 years, the results from ASCO’s 2019 Cancer Opinion Survey revealed some startling answers about the public’s understanding of cancer, its risk factors, and strategies to prevent the disease. Although a majority of Americans (57%) said they were concerned about developing...
FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer
On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...
A Systematic Approach to Identifying the Molecular Factors That Lead to Cancer Progression
Although gene mutations are the primary drivers of carcinogenesis, an array of complex and tumor-specific molecular interaction networks determine cancer cell behavior. To learn more about this line of inquiry, The ASCO Post recently spoke with Andrea Califano, Dr., Professor of Chemical Biology...
FDA Approves Enzalutamide for Patients With Metastatic Castration-Sensitive Prostate Cancer
On December 16, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with metastatic castration-sensitive prostate cancer. The FDA previously approved enzalutamide for patients with castration-resistant prostate cancer. ARCHES Trial Efficacy was investigated in...
Stephen Hahn, MD, Confirmed as FDA Commissioner by Senate
On December 12, the United States Senate voted 72–18 to confirm Stephen Hahn, MD, as Commissioner of the U.S. Food and Drug Administration (FDA). A radiation oncologist, Dr. Hahn was previously the Chief Medical Executive and Gilbert H. Fletcher Distinguished Memorial Chair and Professor of...
Zanubrutinib in Previously Treated Mantle Cell Lymphoma
On November 14, 2019, the oral Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib was granted accelerated approval in the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1,2 Supporting Efficacy Data The approval was based on findings from...
FDA Approves PD-L1 Inhibitor Plus Chemotherapy for First-Line Treatment of Metastatic Nonsquamous Non–Small Cell Lung Cancer
On December 4, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with chemotherapy (nab-paclitaxel and carboplatin) for the first-line treatment of adults with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic...
First-Line Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma
On April 19, 2019, pembrolizumab was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III...
I Do Not Have a Multiple Myeloma Precursor Condition. Why Not?
For the country, and for me personally, 2001 was a watershed year. In May, my mother died; the following month my brother, Dom, then 57, called to tell me he had just been diagnosed with multiple myeloma. Except for some fatigue Dom had complained about at our mother’s funeral, there were no...
Niraparib for Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 23, 2019, the poly (ADP-ribose) polymerase...
FDA Approves Voxelotor for Sickle Cell Disease
On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease. “[Voxelotor] is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central...
ASH 2019: CAR T-Cell Therapy Shows Activity, Reduces Health-Care Utilization in Older Patients With DLBCL
A new analysis of Medicare claims data presented by Kilgore et al at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 793) has provided the first real-world evidence using claims data available after the approval of autologous anti-CD19 chimeric antigen...
ASH 2019: CAR-NK Therapy for B-Cell Malignancies Shows Activity in Preclinical Studies
Preclinical studies have provided the first evidence that cellular immunotherapy for B-cell cancers could ultimately become an off-the-shelf product, capable of being uniformly manufactured in large quantities. The product—FT596—is among the first cellular immunotherapies to be based on...
Promising New Treatments for Triple-Negative Breast Cancer: Immunotherapy and Other Targeted Therapies
Clinical trials continue to demonstrate that combining immunotherapy with chemotherapy and other targeted therapies can improve survival for patients with triple-negative breast cancer, according to results presented at the 21st Annual Lynn Sage Breast Cancer Symposium in Chicago. Nearly 700...
Is Nonmetastatic Castration-Resistant Prostate Cancer a Valid Disease Category?
Does nonmetastatic castration-resistant prostate cancer really exist? Although it is considered a disease category, it turns out that the definition depends on the type of imaging used. Many patients with castration-resistant prostate cancer who were categorized as “nonmetastatic” on conventional...
