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Showing 1051 - 1100Venetoclax Combination in Newly Diagnosed AML
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding...
FDA Issues Emergency Use Authorization for First COVID-19 Test for Self-Testing at Home
On November 17, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. The Lucira COVID-19 All-In-One Test Kit, which provides rapid results, is a molecular (real-time loop mediated amplification...
FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers. Fast Track Designation for SRF388 in Liver Cancer The FDA granted Fast Track designation to SRF388 for the treatment of patients with...
FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1...
Project N95 Partnership Provided ASCO Members With Access to Personal Protective Equipment
The COVID-19 pandemic has made 2020 a challenging year for everyone, including cancer care providers, many of whom have had difficulty obtaining personal protective equipment (PPE) for their patients and staff during the pandemic. To help ease this burden on its members, ASCO partnered with Project ...
Inaugural Class of FDA-AACR Oncology Educational Fellows Announced
The American Association for Cancer Research (AACR) has announced the 2020–2021 class of U.S. Food and Drug Administration (FDA)-AACR Oncology Educational Fellows. This is the first year of the fellowship, a joint initiative of the Oncology Center of Excellence at the FDA and the AACR. The...
Combination of Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma
On October 2, 2020, the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) was approved for first-line treatment of adult patients with unresectable malignant pleural mesothelioma.1-3 Supporting Efficacy Data Approval was based on findings in the open-label phase III CheckMate 743 trial...
Front-Line Avelumab Maintenance Improved Survival Across Subgroups With Advanced Urothelial Carcinoma
A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...
Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Larotrectinib Treatment Approved by FDA
On October 23, 2020, the U.S. Food and Drug Administration (FDA) approved the next-generation sequencing–based FoundationOne CDx test as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue...
Committed to Excellence: Oncology Drug Development Marches on Amid a Pandemic
Instituted as part of the 21st Century Cures Act, the Oncology Center of Excellence (OCE) fosters a unified interaction between three U.S. Food and Drug Administration (FDA) centers: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and...
Richard Pazdur, MD, Awarded the Simon M. Shubitz Cancer Prize and Lectureship
For more than 4 decades, the University of Chicago Cancer Research Foundation’s Simon M. Shubitz Cancer Prize and Lectureship has honored an internationally renowned individual for his or her exceptional contributions to cancer research and clinical care. The recipient of this year’s award is...
FDA Expands Approval of Companion Diagnostic for Olaparib in Prostate Cancer
On November 9, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to be used as a companion diagnostic for olaparib. As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2, and/or ATM alterations and...
FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers
On October 27, 2020, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib...
FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...
Study Finds Further Efforts Needed for Inclusion of Underrepresented Populations in Radiotherapy Clinical Trials
A new study finds that the racial composition of clinical trials involving radiation therapy does not match that of the U.S. population. Examining trials from the past 23 years, researchers found that roughly 12% of trial participants were Black, which is less than the 13% population composition of ...
FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers
On October 27, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqray) in ...
Fluciclovine PET Imaging vs Conventional Imaging in Prostate Cancer
The addition of the radiotracer fluciclovine to positron-emission tomography (PET) imaging for treatment planning led to superior failure-free survival compared with conventional imaging in men with prostate cancer who had undergone radical prostatectomy and were experiencing biologic recurrence of ...
Targeted Inhibitor of Mutant KRAS Gene Shows Activity in Early Trial
Adagrasib (MRTX849), a novel agent that targets a mutated form of the KRAS gene—the most commonly altered oncogene in human cancers, and one long considered “undruggable”—caused tumor shrinkage in most patients in a clinical trial, with manageable side effects, researchers reported at the 32nd...
Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Treatment With Larotrectinib Approved by the FDA
On October 23, the U.S. Food and Drug Administration (FDA) approved the next-generation sequencing–based FoundationOne CDx test as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue specimens ...
Emily Whitehead, Early Recipient of CAR T-Cell Therapy for ALL, Celebrates 8 Years Cancer-Free
Among the success stories in the treatment of acute lymphoblastic leukemia (ALL) in children and young adults is the development of chimeric antigen receptor (CAR) T-cell therapy. The field of cellular immunotherapy was still in its infancy in 2012 when Emily Whitehead, then 7, became the first...
Dana-Farber Announces Center for Salivary and Rare Head and Neck Cancers
Dana-Farber Cancer Institute has launched the Center for Salivary and Rare Head and Neck Cancers to treat patients with rare and occasionally aggressive cancers arising from the head and neck. The Center is among the first in the country specifically dedicated to the care and therapeutic research...
FDA Awards Six Grants to Fund New Clinical Trials of Medical Products for Treatment of Rare Diseases
The U.S. Food and Drug Administration (FDA) announced it has awarded six new clinical trial research grants to principal investigators from academia and industry, totaling more than $16 million over the next 4 years. These grants, awarded through the Congressionally funded Orphan Products Grants...
Thinking Out of the Box to Advance the Management of Chronic Graft-vs-Host Disease
Over the past decade, the field of allogeneic hematopoietic cell transplantation has made great strides, evolving into a curative procedure for blood cancers that once were almost always fatal. However, chronic graft-vs-host disease, whose biologic etiology remains unclear, continues to be the...
Olaparib Improves Outcomes in Metastatic Castration-Resistant Prostate Cancer With BRCA1/2 Alterations
The PARP inhibitor olaparib reduced the risk of death by 31% compared with a second hormonal treatment (enzalutamide or abiraterone) in men with metastatic castration-resistant prostate cancer characterized by BRCA1, BRCA2, or ATM mutations, in the final analysis of the phase III PROfound trial...
Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers
In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...
Recent FDA Approvals in Leukemia and Lymphoma
This week on The ASCO Post Podcast, we'll focus on two recent approvals from the U.S. Food and Drug Administration in patients with leukemia and lymphoma.
FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....
FDA Approves Remdesivir for Patients With COVID-19 Requiring Hospitalization
On October 22, the U.S. Food and Drug Administration (FDA) approved the antiviral drug remdesivir (Veklury) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Remdesivir should only be administered...
FDA Approves Venetoclax Combination Regimen for Certain Adult Patients With AML
On October 16, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have comorbidities precluding intensive ...
FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma
On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications: Adult patients with relapsed or refractory classical Hodgkin lymphoma Pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin...
FDA Pipeline: Designations for Treatments of Rare Blood Cancer, B-Cell Malignancies, and Gastric Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to an antibody-drug conjugate for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN); gave Fast Track designation to a novel chimeric antigen...
Pralsetinib for NSCLC With RET Gene Fusions
On September 4, 2020, pralsetinib (Gavreto) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for treatment of adults with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.1,2 The FDA simultaneously approved the...
A Leader in Drug Development, Patricia Keegan, MD, Reflects on Making a Difference in Cancer Care
In this installment of the Living a Full Life series, guest editor Jame Abraham, MD, spoke with Patricia Keegan, MD, who served at the U.S. Food and Drug Administration (FDA) for 30 years, most recently as Acting Associate Director of Medical Policy at the Oncology Center for Excellence (OCE)....
Carfilzomib and Daratumumab With Dexamethasone for Relapsed or Refractory Multiple Myeloma
On August 20, 2020, carfilzomib and daratumumab were approved for use in combination with dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.1-3 Supporting Efficacy Data Approval was based on findings in two clinical...
HER2-Positive Metastatic Breast Cancer Highlights 2019–2020 Almanac
The past 2 years have seen a dramatic change in the standard of care for patients with HER2-positive metastatic breast cancer whose disease has progressed on trastuzumab. Promising new agents and combinations for later lines of therapy may also challenge current treatment strategies, according to...
Novel Indications and New Drugs for the Treatment of Patients With Breast Cancer
Over the past year (December 2019–September 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for therapeutic agents used in breast cancer. Pertuzumab/Trastuzumab/Hyaluronidase-zzxf On June 29, 2020, the FDA approved a new fixed-dose...
Emerging Alternatives in the Third-Line Setting for Metastatic HER2-Positive Breast Cancer
In the post-trastuzumab era, a number of U.S. Food and Drug Administration (FDA)-approved targeted agents for metastatic HER2-positive breast cancer are available, but there is no preferred option for third-line treatment and beyond. At the 2019 Chemotherapy Foundation Symposium, Shanu Modi, MD,...
Updates From Additional Clinical Trials in HER2-Positive Breast Cancer
Here we present summaries of several additional clinical trials in HER2-positive breast cancer reported over the past year. Jame Abraham, MD, Chair of the Division of Hematology and Oncology at the Taussig Cancer Center, Cleveland Clinic, shared his perspective on several of these trials presented ...
Neratinib in Previously TreatedHER2-Positive Metastatic Breast Cancer: Point of View From the NALA Trial
Neratinib is an oral pan-HER tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration (FDA) for two indications. The first is as adjuvant treatment of early-stage HER2-positive breast cancer following adjuvant trastuzumab therapy. The second is in combination with...
FDA Approves Nivolumab Plus Ipilimumab for the First-Line Treatment of Unresectable Malignant Pleural Mesothelioma
On October 2, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. CheckMate 743 Efficacy was investigated in CheckMate 743, a randomized,...
FDA Pipeline: Priority Review for Agents in Multiple Myeloma, Anaplastic Large Cell Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to therapies for pretreated patients with multiple myeloma and pediatric patients with ALK-positive anaplastic large cell lymphoma; granted Fast Track designation to novel agents in gastric/gastroesophageal junction...
NCCN Adds Tafasitamab-cxix to Its Clinical Practice Guidelines in Oncology for B-Cell Lymphomas
MorphoSys and Incyte have announced that tafasitamab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines® (NCCN Guidelines®) in Oncology for B-Cell Lymphomas. Specifically,...
National Survey Shows Decline in Overall Youth E-Cigarette Use, Uptick in Use of Disposable Products
In september, 2020, the U.S. Food and Drug Administration (FDA), in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS). The results, published by Wang et al in Morbidity and Mortality Weekly Report (MMWR), showed 1.8 ...
Neratinib in Previously Treated HER2-Positive Metastatic Breast Cancer: Point of View From the NALA Trial
Neratinib is an oral pan-HER tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration (FDA) for two indications. The first is as adjuvant treatment of early-stage HER2-positive breast cancer following adjuvant trastuzumab therapy. The second is in combination with...
Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
On July 24, 2020, brexucabtagene autoleucel, a CD19-directed genetically modified autologous T-cell immunotherapy, was granted accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.1,2 Brexucabtagene autoleucel is approved with a Risk Evaluation...
Sentinel Lymph Node Biopsy and Age-Related Mutations: Therapeutic and Predictive Implications in Melanoma
Findings from a study among patients with melanoma randomly assigned to observation following removal of a positive sentinel lymph node “strongly support the therapeutic effect of the sentinel lymph node biopsy in providing long-term regional nodal disease control in the large majority of...
Azacitidine Tablets for Continued Treatment in Acute Myeloid Leukemia
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 September 1, 2020, azacitidine tabletswere approved...
Efforts to Broaden Eligibility Criteria for Clinical Trials Seek to Include More Racial and Ethnic Minority Patients
A review of the 2019 Drug Trials Snapshots Report1 from the U.S. Food and Drug Administration (FDA) showed that although female participation in clinical trials grew to 72% from 56% in the FDA’s 2018 Drug Trials Snapshots Report,2 ethnic minority participation in clinical trials actually declined...
AACR Releases 10th Edition of Annual Cancer Progress Report
The American Association for Cancer Research (AACR) has released the 10th edition of its annual Cancer Progress Report. The report highlights how cancer research, largely supported by federal investments in the National Institutes of Health (NIH) and the National Cancer Institute (NCI), is...
FDA Pipeline: Designations in Prostate Cancer, Glioblastoma, and Pediatric Leukemia
Recently, the U.S. Food and Drug Administration (FDA) granted designations to agents for metastatic castration-resistant prostate cancer, recurrent glioblastoma, and pediatric acute myeloid leukemia. Fast Track Designation for EPI-7386 in Metastatic Castration-Resistant Prostate Cancer The FDA...
