Search Results
Your search for ,Fda matches 3753 pages
Showing 1401 - 1450Sequence 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...
FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma
On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...
Fedratinib: Back From Development Limbo for the Treatment of Myeloproliferative Neoplasms
In September 2019, Dr. Claire Harrison and colleagues, myself among them, presented two new analyses regarding the use of the JAK2 and FLT3 inhibitor fedratinib in myelofibrosis at the Society of Hematologic Oncology (SOHO) Annual Meeting, with resulting publication in Clinical Lymphoma, Myeloma...
Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov...
FDA Awards Research Grants for the Study of Rare Cancers
The U.S. Food and Drug Administration (FDA) recently awarded 12 new clinical trial research grants totaling more than $15 million over the next 4 years, many of them focusing on cancer. Also, the FDA awarded two new research grants for natural history studies in rare diseases, totaling more than...
FDA Approves Luspatercept-aamt for Anemia in Patients With Beta Thalassemia
On November 8, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. Beta thalassemia is a blood disorder that reduces the production of hemoglobin. In...
Addition of Durvalumab to Etoposide Plus Platinum Chemotherapy for Extensive-Stage SCLC
This week, we’ll review an interim analysis of the CASPIAN trial, which evaluated the addition of durvalumab to etoposide plus platinum chemotherapy for extensive-stage small cell lung cancer. Then, we’ll talk about two recently issued guidelines on screening for colorectal cancer. Lastly, we’ll...
Daratumumab Combination Therapy for Patients With Multiple Myeloma Who Are Eligible for Transplantation
On September 26, 2019, daratumu-mab (Darzalex) was approved in combination with bortezomib, thalidomide, and dexamethasone for the treatment of multiple myeloma in newly diagnosed adult patients eligible for autologous stem cell transplantation (ASCT).1,2 Supporting Efficacy Data Approval was based ...
Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals
In a study reported in JAMA Oncology,1Jonathan M. Loree, MD, of BC Cancer, Vancouver, British Columbia, Canada, and colleagues found that race and race subgroup analyses were frequently not included in reported trials supporting U.S. Food and Drug Administration (FDA) oncology drug approvals...
Immunotherapy Combinations Redefine Outcomes for Patients With Advanced Renal Cell Carcinoma
The treatment landscape for patients with advanced renal cell carcinoma has changed drastically over the past several years with the introduction of many new therapeutic options for patients. The revolution began with the U.S. Food and Drug Administration (FDA) approval of nivolumab and ipilimumab...
Personalized Treatment Approaches on the Horizon for Myelodysplastic Syndromes
Despite the spate of recent drug approvals in blood cancer, it’s been more than 13 years since the U.S. Food and Drug Administration (FDA) has approved a treatment for myelodysplastic syndromes (MDS), a bone marrow disorder characterized by ineffective hematopoiesis. Nevertheless, data from a...
FDA Office of Hematology Oncology Products Reorganizes, 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...
FDA Approves Pegfilgrastim Biosimilar
On November 5, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim, pegfilgrastim-bmez (Ziextenzo). Pegfilgrastim-bmez is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving...
Stephen Hahn, MD, to Be Nominated FDA Commissioner
In a press release issued by the White House today, President Donald J. Trump announced his intention to nominate Stephen Hahn, MD, FASTRO, to be the Commissioner of Food and Drugs at the Department of Health and Human Services. Dr. Hahn has been Chief Medical Executive at The University of Texas...
FDA Issues Drug Safety Communication on Lung Inflammation Linked to Treatment With CDK4/6 Inhibitors
On September 13, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The agency approved new warnings about...
FDA Pipeline: Treatments for HER2-Positive Breast Cancer, AML; Breakthrough Device for Prostate Cancer; Statement on Safety Information for Breast Implants
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to trastuzumab deruxtecan for the treatment of HER2-positive metastatic breast cancer; granted Fast Track designation for bemcentinib for elderly patients with relapsed acute myeloid leukemia (AML); granted Breakthrough...
FDA Approves Niraparib for Patients With Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer
On October 23, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination...
Fedratinib for Myelofibrosis
On August 16, 2019, fedratinib was approved for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1,2 Supporting Efficacy Data The approval was based on findings from the phase III double-blind...
City of Hope Enrolling Patients With Brain Tumors in First-of-Its-Kind Clinical Trial
City of Hope has opened a first-in-human clinical trial for patients with recurrent glioblastoma. The trial is the first to combine City of Hope’s chimeric antigen receptor (CAR) T cells that target the IL13Rα2 antigen common on brain tumor cells in combination with nivolumab and ipilimumab. To...
Pembrolizumab/Lenvatinib in Advanced Endometrial Carcinoma Without Microsatellite Instability–High or Mismatch Repair–Deficient Disease
On September 17, 2019, the combination of pembrolizumab plus lenvatinib was granted accelerated approval for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) and who have disease progression...
FDA Approves Label Expansion for Single-Dose Regimen of Intravenous Aprepitant for Patients Receiving Moderately Emetogenic Chemotherapy
On October 22, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for aprepitant (Cinvanti) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130-mg single-dose regimen for...
Update to FDA Prescribing Information for Romiplostim for Adults With Immune Thrombocytopenia
On October 18, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for romiplostim (Nplate) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia. The updated...
The Future of the Radiation Abscopal Response
“Two roads diverged in a wood, and I—I took the one less traveled by,And that has made all the difference.” –Robert Frost One of the first patients I encountered after residency was a 26-year-old woman with a single brain metastasis from melanoma. For anonymity, let’s call her Anna. Anna had just...
FDA Pipeline: Designations for Acute Graft-vs-Host Disease, Peripheral T-Cell Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a therapy for steroid-refractory acute graft-vs-host disease and granted Orphan Drug designation to a therapy for peripheral T-cell lymphoma. Fast Track Designation for T-Guard in Steroid-Refractory Acute...
Pooled Analysis of Outcomes in Older Women With Metastatic Breast Cancer Receiving CDK4/6 Inhibitor Plus Aromatase Inhibitor Therapy
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in the Journal of Clinical Oncology, Howie et al found that progression-free survival and benefit were similar for older vs younger postmenopausal women treated with combined cyclin-dependent kinase 4/6 (CDK4/6) plus aromatase...
Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer
EARLIER THIS YEAR, atezolizumab was granted accelerated approval in combination with nab-paclitaxel in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express programmed cell death ligand 1 (PD-L1–stained tumor-infiltrating...
