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Showing 351 - 400Antihypertensive Drug Combinations May Help Reduce Blood Pressure in Patients Receiving Ibrutinib
Combination therapy with two or more antihypertensive drugs may reduce blood pressure in patients receiving ibrutinib, according to a recent study published by Samples et al in Blood Advances. Background Ibrutinib was the first Bruton tyrosine kinase (BTK) inhibitor to receive U.S. Food and Drug...
Cardio-Oncology Is a Growing Subspecialty, but Where Are the Oncologists?
It has been almost 20 years since the approval of trastuzumab for the treatment of early-stage, HER2-positive breast cancer. I remember returning from the 2005 ASCO Annual Meeting excited to offer patients a treatment that led to significant improvement in clinical outcomes. However, within a short ...
Sotorasib, the Poster Child for Project Optimus: Truths and Fantasies
In January 2021, two of us wrote in these pages about our field’s pressing need to pivot away from identifying and deploying the maximum tolerated dose (MTD) when it comes to targeted oncology therapies.1 We argued that, instead, one should be looking for the “optimal dose”—the dose that best...
Secondary Cancers May Be Rare in Patients Treated With CAR T-Cell Therapy
The development of any type of secondary cancer following chimeric antigen receptor (CAR) T-cell therapy may be rare, according to a recent study published by Ghilardi et al in Nature Medicine. Background Secondary cancers, including T-cell lymphomas, are known risks of cancer treatments such as...
Study Examines Real-World Outcomes With Ivosidenib vs Venetoclax in Acute Myeloid Leukemia
In a comparison of real-world outcomes for two common first-line regimens for acute myeloid leukemia (AML) with mutations in isocitrate dehydrogenase 1 (IDH1), treatment with the IDH1-targeted agent ivosidenib plus a hypomethylating agent was associated with better outcomes than venetoclax plus a...
Generic Drug Shortages and Essential Cancer Medicines
Decisions regarding the rationing of chemotherapy are commonplace in many countries around the world—including those where patients must pay for chemotherapy out of pocket—and increasingly so in cancer settings that treat both well-off and socioeconomically disadvantaged patients. However, these...
FDA Issues Safety Labeling Change Notification to CAR T-Cell Therapy Manufacturers
On January 19, the U.S. Food and Drug Administration (FDA) issued safety labeling change notification letters to all manufacturers of licensed B-cell maturation antigen (BCMA)-directed and CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell immunotherapies requiring ...
George D. Demetri, MD, FASCO, Earns Lifetime Achievement Award in Medicine From Stanford Medicine Alumni Association
George D. Demetri, MD, FASCO, Director of the Sarcoma Center at Dana-Farber Cancer Institute, was awarded the J.E. Wallace Sterling Lifetime Achievement Award in Medicine from the Stanford Medicine Alumni Association (SMAA). Dr. Demetri, an alumnus of the Stanford University School of Medicine,...
The High Cost of Oral Agents for Relapsed and Refractory Multiple Myeloma
Late in 2023, Richardson et al shared the results of a phase I/II clinical trial (ClinicalTrials.gov identifier NCT03374085). They concluded that the “all-oral combination of mezigdomide plus dexamethasone showed promising efficacy in patients with heavily pretreated multiple myeloma.”1 Mezigdomide ...
FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma
On January 19, the U.S. Food and Drug Administration (FDA) approved the FGFR inhibitor erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose...
FDA Approves Pembrolizumab Plus Chemoradiotherapy for FIGO 2014 Stage III–IVA Cervical Cancer
On January 12, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III–IVA cervical cancer. KEYNOTE-A18 Efficacy was evaluated in KEYNOTE-A18...
ALL in Adults: Trial Updates and Clinical Considerations for Selecting Consolidation Therapy
Although pediatric patients with acute lymphoblastic leukemia (ALL) have seen a dramatic improvement in long-term survival rates over the past 40 years, from approximately 10% to over 95%, adults aged 29 and older have not experienced the same treatment benefits, with survival rates still below...
Call to Action Issued to Expand Access to Clinical Trials
A paper published by Harvey et al in the journal Cancer detailed three calls to action that the oncology research and clinical care communities should implement to expand access to clinical trials and improve inclusivity to enable more people with cancer to participate in trials closer to home. The ...
ASCO and Ontario Health Publish New Recommendations for Systemic Therapy in SCLC
A newly published guideline update from ASCO and Ontario Health provides evidence-based recommendations on the use of systemic therapy for small cell lung cancer (SCLC).1 Recommendations cover where novel agents fit in the treatment landscape, the management of disease in older patients with...
I Don’t Want Cancer to Define Me
Except for a series of unexplained multiple broken bones and inexplicable excruciating pain in my right hip and leg, I had no other hallmarks of multiple myeloma when I was diagnosed with the disease at age 48 in 2014. My blood test values were all normal, and I didn’t have anemia or kidney damage. ...
FDA Approves Enfortumab Vedotin-ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer
On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer. The FDA previously granted accelerated approval to this combination for patients...
FDA Approves Belzutifan for Advanced Renal Cell Carcinoma
On December 14, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg) for patients with advanced renal cell carcinoma following treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor. LITESPARK-005 Efficacy was...
FDA Approves Eflornithine for Adult and Pediatric Patients With High-Risk Neuroblastoma
On December 13, the U.S. Food and Drug Administration approved eflornithine (Iwilfin), an irreversible inhibitor of ornithine decarboxylase, to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior...
Novel CAR T-Cell Therapy May Show Early Efficacy in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Early results from a new study have demonstrated that the novel chimeric antigen receptor (CAR) T-cell therapy AT101 resulted in favorable complete response rates at higher dose levels in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, according to new findings simultaneously...
Encorafenib Plus Binimetinib in Metastatic NSCLC With BRAF V600E Mutation
On October 11, 2023, the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) was approved for patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA...
FDA Grants Accelerated Approval to Pirtobrutinib for CLL/SLL
On December 1, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine...
FDA Investigating Risk of T-Cell Malignancy Following BCMA- or CD19-Directed Autologous CAR T-Cell Immunotherapies
The U.S. Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor (CAR)-positive lymphoma, in patients who received treatment with B cell maturation antigen (BCMA)- or CD19-directed autologous CAR T-cell immunotherapies. Reports were...
FDA Approves Nirogacestat for Desmoid Tumors
On November 27, the U.S. Food and Drug Administration (FDA) approved the selective gamma secretase inhibitor nirogacestat (Ogsiveo) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. DeFi Trial Efficacy was...
Highlights From the 2023 World Conference on Lung Cancer
The management of lung cancer and other thoracic malignancies has evolved significantly over the past decade. Thanks to many scientific advancements in the field, new therapeutic options, and improvements in screening and early detection, more patients are being cured, and many others are living...
Updates in Lower-Risk Myelodysplastic Syndromes/Neoplasms
Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal hematopoietic stem cell disorders that are characterized by ineffective hematopoiesis, resulting in cytopenias, and they carry a risk of progression to acute myeloid leukemia (AML). In 2022, the fifth edition of the World Health ...
Optimizing Treatment Selection for Newly Diagnosed and Secondary AML: Focus on Cytogenetic and Molecular Data
Greater understanding of biological disease factors in acute myeloid leukemia (AML) has led to more effective and personalized treatment options. At the 2023 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic Malignancies,1 Rebecca Olin, MD, MSCE, of UCSF Helen Diller Family...
FDA Approves Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence
On November 16, the U.S. Food and Drug Administration (FDA) approved the androgen receptor inhibitor enzalutamide (Xtandi) for patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. EMBARK Trial Efficacy was evaluated in EMBARK...
AACR Annual Cancer Progress Report Highlights Scientific Advances Against Cancer, Challenges and Opportunities Ahead
The remarkable progress in medical research—primarily supported by federal investments in the National Institutes of Health (NIH) and the National Cancer Institute (NCI)—over the past 3 decades, coupled with advances in prevention and early detection, has led to a 33% reduction in cancer...
FDA Approves Capivasertib With Fulvestrant for Breast Cancer
On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, as detected by an...
FDA Approves Next-Generation Tyrosine Kinase Inhibitor Repotrectinib for ROS1-Positive NSCLC
On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved the next-generation tyrosine kinase inhibitor repotrectinib (Augtyro) for the treatment of locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC). According to the American Lung Association, the ROS1 ...
FDA Approves First Treatment for Patients With Rare Congenital Blood Disorder
On November 9, the U.S. Food and Drug Administration (FDA) approved ADAMTS13, recombinant-krhn (Adzynma), the first genetically engineered protein product indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic...
FDA Amends Pembrolizumab’s Gastric Cancer Indication
On November 7, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda) in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
FDA Approves Fruquintinib for Refractory Metastatic Colorectal Cancer
On November 8, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and—if their disease is RAS wild-type and it...
2023 National Youth Tobacco Survey Shows Drop in E-Cigarette Use Among High School Students
On November 2, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings—which were collected between March and June 2023 and were...
FDA Approves Pembrolizumab Plus Chemotherapy for Biliary Tract Cancer
On October 31, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) to be used with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. KEYNOTE-966 Efficacy was evaluated in KEYNOTE-966...
FDA Approves Toripalimab-tpzi for Nasopharyngeal Carcinoma
On October 27, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for...
FDA Approves Ivosidenib for Myelodysplastic Syndromes
On October 24, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. The FDA also approved the...
ASCO Response to Drug Shortages Request for Information
The Association for Clinical Oncology (ASCO) responded to a bicameral Request for Information (RFI) on the underlying factors driving drug shortages. The Association’s comments highlighted the impact of the shortages on patient care and pointed to economic failures and supply chain vulnerabilities...
FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation
On October 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the small-molecule tyrosine kinase inhibitor entrectinib (Rozlytrek) for pediatric patients aged 1 month and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion...
Is Idecabtagene Vicleucel Effective in Patients With Multiple Myeloma, Regardless of Race?
The chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel may offer an overall survival benefit in patients with multiple myeloma, regardless of their race or ethnicity, according to a novel study published by Peres et al in Blood Advances. Background Multiple myeloma—a cancer of...
Almost Half of Oncology Drugs Approved Since 1998 Have Been Precision Therapies, New Study Finds
Among the 198 new oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 1998 and 2022, approximately 43% of them were precision therapies, according to a recent study published by Suehnholz et al in Cancer Discovery. Background Precision oncology therapies often require...
FDA Approves Neoadjuvant/Adjuvant Pembrolizumab for Resectable NSCLC
On October 16, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment, for resectable (tumors ≥ 4 cm or node-positive)...
Recent FDA Approvals in Breast Cancer
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and expanded indications for older therapeutic agents used in breast cancer. Abemaciclib Plus Endocrine Therapy On March 3, 2023, the FDA expanded the indication for abemaciclib with endocrine...
FDA Approves Adjuvant Nivolumab for Stage IIB/IIC Melanoma
On October 13, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the adjuvant treatment of completely resected stage IIB or IIC melanoma in patients aged 12 years and older. CheckMate 76K Efficacy was evaluated in CheckMate 76K (ClinicalTrials.gov identifier NCT04099251),...
FDA Approves Encorafenib With Binimetinib for Metastatic BRAF V600E–Mutated NSCLC
On October 11, the U.S. Food and Drug Administration (FDA) approved the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer (NSCLC) and a BRAF V600E mutation, as detected by an FDA-approved test. The FDA...
FDA Grants Marketing Authorization to Edison Histotripsy System for Treatment of Liver Tumors
On October 9, HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the marketing authorization of its platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical...
Accelerated Approval Granted for Use of Elranatamab-bcmm in Relapsed or Refractory Multiple Myeloma
On August 14, 2023, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager elranatamab-bcmm was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of...
Tracking the Progress Being Made in the Treatment of Breast Cancer and the Challenges Ahead
Jame Abraham, MD, FACP, has been in the field of oncology for more than 2 decades, he and says this is both one of the most exhilarating and challenging times in cancer care. “What excites me the most are the innovations in treatment that are literally transforming the lives of our patients and...
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
On September 29, the U.S. Food and Drug Administration (FDA) granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that may help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The...
FDA Approves Bosutinib for Pediatric Patients With Chronic Myelogenous Leukemia
On September 26, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif) for pediatric patients aged 1 year and older with chronic-phase, Philadelphia chromosome–positive chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy. The FDA ...
