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Showing 1451 - 1500Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...
Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...
Insightful Advice From a College Advisor Leads to an Unexpected Career in Oncology
For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with Tatiana M. Prowell, MD, who currently serves as Associate Professor of Oncology in the Breast Cancer Program at the Johns Hopkins Kimmel Comprehensive Cancer Center and as a Medical Officer and...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence
Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to...
Update on FDA-Approved CAR T-Cell Gene Therapy for B-Cell Lymphomas
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
On August 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...
FDA Approves Fedratinib for Treatment of Myelofibrosis
On August 16, the U.S. Food and Drug Administration (FDA) approved the Janus kinase 2 (JAK2) inhibitor fedratinib (Inrebic) for the treatment of adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to [this...
FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
New Report Finds Cancer Drugs Account for Over a Quarter of All New Drug Approvals in the United States
Cancer drugs currently account for 27% of all new drug approvals in the United States since 2010—an increase from the 4% share they occupied in the 1980s, a newly completed analysis summarized in the most recent issue of the Tufts CSDD Impact Report. From 1980 through 2018, the U.S. Food and Drug...
2019 Quality Care: Clinical Trial Enrollment May Be Associated With Reduced Mortality in Patients With Metastatic Lung Cancer
Researchers from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle investigated the relationship between participation in a clinical trial and overall survival in patients with advanced non–small cell lung cancer (NSCLC). Cristina Merkhofer, MD, MHS, will present...
FDA Recommendation on Duodenoscopes With Disposable Components
The U.S. Food and Drug Administration (FDA) has recommended that duodenoscope manufacturers and health-care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse and persistent...
Pooled Survival Analysis of Patients With NSCLC Treated With Nivolumab
This week, we review a pooled analysis of long-term survival rates in patients with previously treated non–small cell lung cancer treated with nivolumab. We then turn to the recently reported USPSTF recommendation on risk assessment, genetic counseling, and genetic testing for BRCA1 or BRCA2...
FDA Issues Draft Guidance Encouraging Inclusion of Male Patients in Breast Cancer Clinical Trials
A draft guidance issued by the U.S. Food Drug Administration (FDA) on August 26 includes draft recommendations for the inclusion of male patients in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer, or inclusion of...
FDA Clears Next-Generation Scalp-Cooling Device
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Some Practices May Not Be Subject to USP and Standards
ASCO recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards–Sterile Preparations and USP General Chapter <800> Hazardous Drugs–Handling in Health-Care Settings, which become...
Register for ASCO’s Research Community Forum 2019 Annual Meeting
Registration is open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician-investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of research...
Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned ...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Selinexor in Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel hematology and 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 July 3, 2019, the oral nuclear export...
FDA Clears Next-Generation Scalp-Cooling Device
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor
ON AUGUST 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. ...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
ON JULY 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic ...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
ON AUGUST 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to treat patients ...
FDA Pipeline: Priority Reviews in Prostate Cancer, Mantle Cell Lymphoma
This week, the U.S. Food and Drug Administration (FDA) accepted new drug applications for enzalutamide in metastatic hormone-sensitive prostate cancer and zanubrutinib in relapsed or refractory mantle cell lymphoma, and granted both applications Priority Review. Priority Review for Enzalutamide in ...
Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first...
FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic esophageal cancer whose tumors express programmed cell death ligand 1...
Atezolizumab Plus Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Lung Cancer
In late 2018, atezolizumab was approved for use in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberration.1,2 Supporting Efficacy Data Approval was ...
Racial Reporting and Representation in Oncology Trials
New research published by Loree et al in JAMA Oncology found that race and race subgroup analysis reporting does not occur frequently and that black and Hispanic populations are underrepresented in oncology trials that have led to U.S. Food and Drug Administration (FDA) approvals. The study raises...
FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence
Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to...
FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...
FDA Approves Fedratinib for Myelofibrosis
Today, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic) for adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...
FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson's Disease Treatments Containing Entacapone
A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial—the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's...
Remembering Michael D. Becker
The staff of The ASCO Post were sad to learn of the passing of Michael D. Becker on July 9, 2019. When Michael was diagnosed with human papillomavirus (HPV)-related oropharyngeal cancer in 2015, he made the decision to go public with his diagnosis to raise awareness of the importance of having...
Pembrolizumab for Advanced Merkel Cell Carcinoma
Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified,...
COTA Signs Research Collaboration Agreement With FDA
COTA, Inc, a precision medicine technology company, announced that it has signed a 2-year Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency’s data science and technology incubator that...
Pembrolizumab in Metastatic Small Cell Lung Cancer
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Preserving Sexuality and Restoring Sexual Function in Male and Female Cancer Survivors
Intimacy changes after a cancer diagnosis. Both male and female survivors can experience significant sexual dysfunction, pain with sex, loss of desire, and a slew of other clinical and psychological sequelae. To make matter worse, sexual function is often not discussed by patients and their...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, atezolizumab was approved for use in combination with carboplatin and etoposide in the first-line treatment of adult patients with extensive-stage small cell lung cance (SCLC).1,2 Supporting Efficacy Data Approval was based on findings in the phase III double-blind IMpower133...
Global Coalition for Adaptive Research in Glioblastoma
The Global Coalition for Adaptive Research (GCAR) announced recently that the GBM AGILE clinical trial is opening its first clinical site, the Henry Ford Cancer Institute, and has begun enrolling patients. GBM AGILE is the world’s first global adaptive clinical trial platform for glioblastoma and...
FDA Requests Manufacturer Recall of Some Textured Breast Implants
On July 24, the U.S. Food and Drug Administration (FDA) requested that Allergan, the manufacturer of a specific type of textured breast implant, recall specific models of its textured implants from the U.S. market due to the risk of breast implant–associated anaplastic large cell lymphoma (ALCL)....
FDA Approves Rituximab Biosimilar
On July 24, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr -(Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangi-itis....
Notable Presentations at ASCO 2019 Included Studies in Sarcoma, Lymphoma, Myeloma, and Breast and Kidney Cancers
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with...
FDA Pipeline: Breakthrough Therapy for Melanoma, Investigational New Drug for Advanced Solid Tumors
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors. Breakthrough...
Overall Survival in MONALEESA-7
This week, we discuss an interim analysis of the MONALEESA-7 trial of the addition of ribociclib to endocrine therapy in pre- or perimenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer. We also talk about a study that examined the relationship between the duration...
