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Showing 1101 - 1150Recent 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...
Enthusiastic Response to Novel Therapies on the Horizon in Multiple Myeloma
Clinicians who treat multiple myeloma can anticipate a host of new treatments: melflufen, cereblon E3 ligase (CEL) modulators, antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor (CAR) T-cell therapies. Kenneth C. Anderson, MD, Director of the Jerome Lipper Multiple...
National Survey Shows Decline in Overall Youth E-Cigarette Use, Uptick in Use of Disposable Products
This week, 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), show 1.8 million...
Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
On August 5, 2020, the antibody-drug conjugate belantamab mafodotin-blmf was granted accelerated approval for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, ...
Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes
On July 7, 2020, an oral combination of the nucleoside metabolic inhibitor decitabine and the cytidine deaminase inhibitor cedazuridine was approved for treatment of adult patients with myelodysplastic syndromes (MDS), including: Previously treated and untreated, de novo, and secondary MDS with the ...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 trial ...
LUNGevity, FDA Launch Lung Cancer Patient Research Project
LUNGevity Foundation, a nonprofit organization focused on lung cancer, recently announced the launch of a new longitudinal study in collaboration with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. The project, understanding the lung cancer patient experience in the...
Setting an Ambitious Path to Ensure Health Equity for All Patients With Cancer
In keeping with her Presidential theme of “Equity: Every Patient, Every Day, Everywhere,” in July, ASCO President Lori J. Pierce, MD, FASTRO, FASCO, announced the Society was joining forces with the Association of Community Cancer Centers (ACCC) to increase racial and ethnic minority participation...
Avelumab in Maintenance Treatment of Urothelial Carcinoma
On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter, ...
Update on Novel Immunotherapies for Plasma Cell Disorders
In this installment of The ASCO Post’s Hematology Expert Review, we take a closer look at the monoclonal antibody targeting CD38, daratumumab, in the treatment of amyloid light chain (AL) amyloidosis and resistant multiple myeloma as well as the antibody-drug conjugate belantamab mafodotin-blmf,...
Chasing Cancer: Challenges to Providing Appropriate Care in the Age of COVID-19
The global impact of the novel coronavirus cannot be overstated, but its effects on cancer care delivery in the United States have been particularly far-reaching. The COVID-19 pandemic has resulted in fewer cancer screenings and reduction in the treatment of new cancers. As a result, the National...
How Delays in Screening and Early Cancer Diagnosis Amid the COVID-19 Pandemic May Result in Increased Cancer Mortality
Earlier this year, as the COVID-19 pandemic was spreading across the United States, federal health officials and cancer societies urged Americans to delay routine cancer screenings and other elective procedures to keep them out of clinics to avoid potential exposure to the coronavirus and to...
Implementation of RACE for Children Act Helps Address Unmet Needs of Children With Cancer
The following statement was recently issued by Monica M. Bertagnolli, MD, FACS, FASCO, Chair of the Association for Clinical Oncology, the affiliate organization of the Society: ASCO applauds implementation of the Research to Accelerate Cures and Equity (RACE) for Children Act. Applications to the ...
FDA Issues Alert About Efficacy and Potential Safety Concerns Regarding Atezolizumab Plus Paclitaxel in Metastatic Triple-Negative Breast Cancer
On September 8, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated, inoperable, locally advanced or metastatic...
FDA Approves Pralsetinib for Metastatic RET Fusion–Positive NSCLC
On September 4, the U.S. Food and Drug Administration (FDA) approved pralsetinib (Gavreto) for the treatment of adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. The approval is based on data from the phase I/II ARROW...
FDA Pipeline: Priority Reviews in Multiple Myeloma, Metastatic Breast Cancer, and NSCLC
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for the treatment of refractory multiple myeloma, metastatic breast cancer, and metastatic non–small cell lung cancer (NSCLC); gave Fast Track designation to treatments for NTRK mutation–positive solid tumors...
Novel Drug Approvals and New Indications for Gynecologic Cancers
A number of new drugs and novel indications were added to the treatment armamentarium for gynecologic cancers over the past year. The U.S. Food and Drug Administration (FDA) approvals are noted here. Olaparib, PARP Inhibitor On May 8, 2020, the FDA expanded the indication of olaparib (Lynparza) to...
Expert Point of View: Thomas J. Herzog, MD
Thomas J. Herzog, MD, Deputy Director, University of Cincinnati Cancer Center, who presented a distillation of the PRIMA trial data along with updated results of the phase III PAOLA-1 trial of olaparib plus bevacizumab maintenance, called the data “practice-changing.” “We’ve suspected for a while...
SGO 2020: Updated Data From PRIMA Trial: Niraparib as First-Line Maintenance Therapy for Advanced Ovarian Cancer
Making sense of maintenance therapy in advanced ovarian cancer has been a tall order since the publication of impressive data for not one but three poly (ADP-ribose) polymerase (PARP) inhibitors at the European Society for Medical Oncology (ESMO) 2019 Congress.1 The picture became a little clearer...
Clinical Perspective on PAOLA-1: Maintenance Therapy for Advanced Ovarian Cancer
Based on multiple phase III prospective trials, there is evidence that both poly (ADP-ribose) polymerase (PARP) inhibitors and antiangiogenic therapies such as bevacizumab provide benefit when utilized in a maintenance strategy in the first-line treatment of advanced epithelial ovarian cancer (GOG...
Gynecologic Oncology Highlights 2019–2020 Almanac
Ovarian cancer is associated with the highest risk of mortality among the five most common gynecologic cancers (cervical, ovarian, uterine [endometrial], vaginal, and vulvar) in the United States; in 2020 in the United States, ovarian cancer will be diagnosed in an estimated 21,750 women, and...
FDA Approves Oral Azacitidine as Maintenance Therapy for Adults With AML in First Remission
On September 1, the U.S. Food and Drug Administration (FDA) approved oral azacitidine (Onureg; also known as CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery...
FDA Approves FoundationOne Liquid CDx, a Pan-Tumor Liquid Biopsy Test
On August 28, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test for patients with solid tumors. FoundationOne Liquid CDx is a comprehensive genomic-profiling test that analyzes more than 300 cancer-related genes and multiple...
RET Inhibitor Selpercatinib Achieves Durable Responses in Majority of Patients With RET Gene Fusions
For patients with non–small cell lung cancers (NSCLC) marked by RET gene fusions, the targeted therapy selpercatinib was well tolerated and achieved durable objective responses in the majority of participants in the phase I/II LIBRETTO-001 trial, according to researchers from The University of...
Transoral Robotic Surgery May Improve Outcomes in Early-Stage Oropharyngeal Cancer
Robotic surgery for patients with early-stage oropharyngeal squamous cell cancer may be associated with improved health outcomes, including better long-term survival, according to a study published by Nguyen et al in JAMA Oncology. Transoral robotic surgery is a minimally invasive procedure in...
How the First International Summit on Interventional Pharmacoeconomics Is Sparking Discussion on Reducing Cancer Costs
Three years ago, former Chief Executive Officer of ASCO, Allen S. Lichter, MD, Laurence H. Baker, DO, Professor in the Departments of Internal Medicine and Pharmacology at the University of Michigan Medical School in Ann Arbor; Leonard Saltz, MD, a gastrointestinal oncologist at Memorial Sloan...
