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Showing 1351 - 1400Trastuzumab 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...
Sequence of Therapies for Metastatic Castration-Resistant Prostate Cancer
We’ll start with a trial focused on the sequence of therapies for metastatic, castration-resistant prostate cancer. Then, we’ll move on to an abstract presented at a recent American Heart Association meeting about the link between increased cardiovascular disease risk and increased cancer risk....
FDA Approves Atezolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On December 4, 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 tumor...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Alpelisib/Fulvestrant Treatment in Breast Cancer
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 female patients as well as male patients with hormone receptor (HR)-positive, HER2-negative,...
Biomarker-Driven Treatment Selection for Prostate and Other Genitourinary Cancers
As the Nobel Laureate Bob Dylan wrote, “The times they are a-changin’.” Heather Cheng, MD, PhD, Associate Professor, University of Washington, Associate Member, Fred Hutchinson Cancer Research Center, and Director, Seattle Cancer Care Alliance, Prostate Cancer Genetics Clinic, quoted this line in...
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,...
Reports From the ESMO Asia Congress 2019
This week, we summarize two studies presented at the recent ESMO Asia Congress—one on a novel combination therapy for unresectable liver cancer, and the second on the activity of a Chinese-manufactured trastuzumab biosimilar. We’ll also discuss last week’s FDA approval of acalabrutinib for chronic...
FDA Pipeline: Recent Designations in Hepatocellular Carcinoma, Cholangiocarcioma, Lymphoma, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) granted reviews or designations to treatments for gastrointestinal cancers and lymphoma, and also provided authorizations for products designed to screen for malignancies and tumor mutational burden. Priority Review for Nivolumab...
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...
ASCO Statement Says FDA Should Implement Proposed Rule for Graphic Labels on Cigarette Packs and Ads
ASCO submitted comments to the U.S. Food and Drug Administration (FDA) applauding its proposed rule to implement the use of new graphic warning labels on cigarette packaging and advertisements. The comments were sent in a letter from 2019–2020 ASCO President Howard A. Burris III, MD, FACP, FASCO, ...
ASCO President-Elect Candidates Discuss Key Issues in Oncology
Patrick J. Loehrer, MD, FASCO, of the Indiana University Melvin and Bren Simon Cancer Center, and Everett E. Vokes, MD, FASCO, of the University of Chicago Medicine Comprehensive Cancer Center, were selected by the ASCO Nominating Committee as candidates for President-Elect. Below, they discuss...
Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia
In late 2018, calaspargase pegol-mknl, an asparagine-specific enzyme, was approved for use as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.1,2 The new product provides for a longer interval ...
Trifluridine/Tipiracil in Recurrent, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Early in 2019, trifluridine/tipiracil tablets were approved for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine; a platinum; either a taxane or...
FDA Office of Hematology Oncology Products Reorganized, Renamed Office of Oncologic Diseases
As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...
Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, 2019, apalutamide was approved for the treatment of patients with metastatic castration-sensitive prostate cancer.1,2 Supporting Efficacy Data The approval is based on overall survival and radiographic progression-free survival findings in the phase III double-blind TITAN trial.2,3 ...
Confirmation Hearing for FDA Commissioner Nominee Stephen Hahn, MD
On November 20, 2019, Stephen Hahn, MD, President Trump’s nominee to be the next Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor, and Pension Committee and answered wide-ranging questions relating to the many important roles the...
Selinexor/Dexamethasone in Refractory Multiple Myeloma: The STORM Has Arrived, but Does It Represent Climate Change?
The term “relapsed/refractory multiple myeloma” is often used to describe advanced myeloma that has progressed through primary or salvage therapy. The International Myeloma Working Group (IMWG) defined the term in 2011 as disease that is “nonresponsive while on salvage therapy or progresses...
Answers to Hematology Expert Review Questions
Question 1 Which of the following statements about cytokine-release syndrome and neurotoxicity after tisagenlecleucel infusion is correct? Correct answer: B. The median time to onset of cytokine-release syndrome is 3 days. Expert Perspective Following tisagenlecleucel infusion, cytokine-release...
CAR T-Cell Gene Therapy: Toxicities and Management Principles
“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” —Marie Curie The ASCO Post is pleased to present Hematology ...
Project Socrates: An Educational Bridge From the FDA to the Public
OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Jennifer J. Gao, MD, Acting Associate Director of Education in the OCE, and Richard Pazdur, MD, Director of ...
Glasdegib in Older Patients With AML or Those With Comorbidities
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, the Hedgehog pathway inhibitor glasdegib...
Nivolumab Plus Bevacizumab for Relapsed Ovarian Cancer
According to findings from a phase II trial, the combination of nivolumab and bevacizumab has shown activity in relapsed ovarian cancer—we discuss those findings reported in JAMA Oncology. Next, we’ll move on to a session from CHEST 2019 which outlined palliation techniques that may be of use to...
FDA Approves Givosiran for Acute Hepatic Porphyria
On November 20, the U.S. Food and Drug Administration (FDA) approved givosiran (Givlaari) for adults with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme. “This buildup can cause acute attacks, known...
FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis
On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...
Two Societies Issue Statements on E-Cigarettes
Today, the American Cancer Society (ACS) announced an update to the organization’s position on e-cigarettes, and the American Medical Association (AMA) called for a total ban on all e-cigarette and vaping products that do not meet U.S. Food and Drug Administration (FDA) approval as cessation ...
ADMIRAL Trial of Gilteritinib vs Salvage Chemotherapy in FLT3-Mutated Acute Myeloid Leukemia
The ADMIRAL trial evaluated gilteritinib vs salvage chemotherapy in FLT3-mutated acute myeloid leukemia—we'll discuss recently reported overall survival results from The New England Journal of Medicine. Then, we’ll move onto findings from a pooled analysis of the relationship between lung cancer...
