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Showing 1101 - 1150Enthusiastic 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...
Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell 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. On July 31, 2020, tafasitamab-cxix, a CD19-directed...
Switch Control Inhibitor for GISTs Harboring Drug-Resistance Mutations: The INVICTUS Trial
In May 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib for patients who have received prior treatment with three or more kinase inhibitors, including imatinib, for advanced gastrointestinal stromal tumors (GIST). The approval was largely based on the findings of the...
Chemotherapy-Free Approaches in Follicular and Mantle Cell Lymphomas
As chemotherapy and chemoimmunotherapy regimens reach their maximal impact in follicular lymphoma and mantle cell lymphoma, clinicians are turning to chemotherapy-free approaches to achieve better control, less toxicity, and (hopefully) a cure. During the ASCO20 Virtual Education Program, Sonali M. ...
Past CMS and FDA Head Discusses Challenges in U.S. Health-Care Policy and Possible Solutions
As evidenced at this year’s ASCO20 Virtual Scientific Program, oncology science, technology, and clinical practice are evolving at a rapid pace, bringing new challenges to the efficient and ethical practice of cancer care at all levels. To shed light on some of the large-scale public health and...
FDA Approves Daratumumab Plus Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On August 20, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy....
FDA Pipeline: Priority Reviews for Immunotherapy Dose Regimen, Small Cell Lung Cancer; Fast Track Designations in Brain Cancer and Leukemia
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for a novel dosing regimen for durvalumab as well as for trilaciclib in small cell lung cancer; granted Fast Track designations to treatments for glioblastoma and B-cell acute lymphoblastic leukemia; and issued reports...
Tumor Mutational Burden and the Future of Complex Biomarkers
The development of complex biomarkers such as tumor mutational burden (TMB) has enabled clinicians to identify patients more likely to respond to treatment of a variety of cancers, leading to more accurate diagnoses and improved outcomes. Differences in testing assays, however, have produced...
Balancing Efficacy and Safety of Targeted Therapy in Breast Cancer Care
Novel targeted therapies have increased the likelihood of cure and prolonged survival in many patients with advanced breast cancer (Table 1), but these new agents also carry toxicity profiles that vary greatly from those of traditional chemotherapy. During the ASCO20 Virtual Education Program,...
Expert Point of View: Amit Mahipal, MBBS, MPH
Amit Mahipal, MBBS, MPH, Consultant, Associate Professor of Oncology, Mayo College of Medicine, Rochester, put the findings for tremelimumab/durvalumab into context regarding other studies evaluating checkpoint inhibitors in advanced hepatocellular carcinoma. In the current study by Kelly et al, he ...
FDA Pipeline: Approval for First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic; Designations in Ovarian Cancer, Leukemia, and Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with non–small cell lung cancer (NSCLC) and specific types of EGFR mutations. The FDA also granted Fast Track...
Novel Indications and New Drugs for the Treatment of Bladder Cancer
Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for 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...
Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented during the ASCO20 Virtual Scientific Program by Elizabeth R....
Nonmetastatic Castration-Resistant Prostate Cancer
Nonmetastatic castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to androgen-deprivation...
Novel Indications and New Drugs for Castration-Resistant or Castrate-Sensitive Prostate Cancer
The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of drugs for treatment of patients with metastatic castrate-resistant prostate cancer or castrate-sensitive prostate cancer. Castrate-Resistant Prostate Cancer Olaparib: On May 19, 2020, olaparib...
Final Analysis of the ARAMIS Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer
A year ago, initial results from the double-blind, multicenter, randomized phase III ARAMIS clinical trial evaluating the efficacy and safety of darolutamide, a structurally unique androgen-receptor antagonist, in men with nonmetastatic castration-resistant prostate cancer, were published in The...
Genitourinary Oncology Highlights 2019–2020 Almanac
Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...
Physicians, New Drugs, and Pharma
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved record numbers of new cancer drugs recently. This is extraordinarily good news for physicians, patients, and drug companies, but it raises important questions as to how effective these drugs are, whether...
Pembrolizumab for Cutaneous Squamous Cell Carcinoma
On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 trial ...
Pembrolizumab for First-Line Treatment of Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
On June 29, 2020, pembrolizumab was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer.1 Supporting Efficacy Data Approval was based on findings in the randomized,...
Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML
On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...
Selinexor in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 22, 2020, the oral nuclear export inhibitor selinexor was granted accelerated approval for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic...
Fixed-Dose Subcutaneous Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in HER2-Positive Breast Cancer
On June 29, 2020, a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) for subcutaneous injection was approved for the following indications1,2: Use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced,...
Highlights of Research in Lymphomas Presented During the EHA25 Virtual Congress
To complement The ASCO Post’s continued coverage of the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual), here are a few abstracts selected from the meeting proceedings focusing on clinical research in Hodgkin and marginal zone lymphomas. Omission of...
Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma
On June 18, 2020, the EZH2 inhibitor tazemetostat was granted accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test, and who have...
NCCN Clinical Practice Guidelines in Oncology: 2020 Updates
In 1996, the National Comprehensive Cancer Network (NCCN) published its first set of Clinical Practice Guidelines in Oncology®, covering eight tumor types. Guidelines are now published for more than 60 tumor types and topics. During the NCCN’s 25th Annual Conference, which was held virtually during ...
