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Showing 351 - 400A Clinical Trial for Bladder Cancer Gave Me Back My Life
About 8 years ago, I was just a few years into menopause when I noticed blood in my urine. It wasn’t accompanied by pain, frequent urination, or any other troubling symptoms, so initially I wasn’t too concerned. But when I started passing pieces of tissue, I became alarmed and made an appointment...
From Fatal to Fearless: How Patients Can Take Control of Their Disease and Fear Cancer Less
In 1996, at the age of 37, Kathy Giusti was diagnosed with the incurable blood cancer multiple myeloma and told she had about 3 years to live. In the mid-1990s, effective therapies for this second most common blood cancer were nearly nonexistent. Standard of care for myeloma consisted of oral...
FDA Approves Safety Labeling Changes Regarding DPD Deficiency for Fluorouracil Injection Products
On March 21, the U.S. Food and Drug Administration (FDA) approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between the FDA’s Office of Generic Drugs and the Oncology Center of Excellence. Fluorouracil injection was initially approved in 1962. The...
Incidence of Secondary T-Cell Malignancies Following CAR T-Cell Therapy
Investigators have found that second primary malignancies following chimeric antigen receptor (CAR) T-cell therapy were reported in 4.3% of CAR T-cell therapy adverse event reports submitted to the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System, with T-cell malignancies...
Adjuvant Pembrolizumab: A New Option for High-Risk Muscle-Invasive Urothelial Cancer
Adjuvant use of the PD-1 inhibitor pembrolizumab achieved a statistically significant and clinically meaningful improvement in disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma vs observation after surgical resection, according to an interim analysis of the phase ...
Osimertinib With Chemotherapy for EGFR-Mutated NSCLC
On February 16, 2024, osimertinib (Tagrisso) was approved by the U.S. Food and Drug Administraton (FDA) with pemetrexed and platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with tumors having EGFR exon 19 deletions or exon 21 L858R...
FDA Grants Accelerated Approval to Ponatinib With Chemotherapy for Newly Diagnosed Philadelphia Chromosome–Positive ALL
On March 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the multitarget kinase inhibitor (Iclusig) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). PhALLCON Efficacy was evaluated in...
Accelerated Approval Granted to First CAR T-Cell Therapy for Relapsed or Refractory CLL/SLL
On March 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small...
FDA Approves Tislelizumab for Previously Treated Patients With Advanced Esophageal Cancer
On March 14, the U.S. Food and Drug Administration (FDA) approved the humanized immunoglobulin G4 anti–PD-1 monoclonal antibody tislelizumab-jsgr (Tevimbra) as monotherapy for adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not...
Novel Dual-Target CAR T-Cell Therapy for Recurrent Glioblastoma
Targeting two brain tumor–associated proteins with chimeric antigen receptor (CAR) T-cell therapy may reduce solid tumor growth in patients with recurrent glioblastoma, according to results from a phase I trial published by Bagley et al in Nature Medicine. The findings suggest that the new...
Immunotherapy Trials for Metastatic NSCLC: FDA Pooled Analysis
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Bernardo Haddock Lobo Goulart, MD, and colleagues found that response rate and progression-free survival were only moderately correlated with overall survival in first-line immunotherapy trials for...
I Am Young and Fit—and Have Stage IV Alveolar Soft-Part Sarcoma
Except for my right thigh being bigger than my left thigh, there was no hint that I was harboring advanced alveolar soft-part sarcoma when I was diagnosed with the cancer in 2019. I initially chocked up the discrepancy in my legs to the vigorous workouts I had received during my cheerleading days,...
Olaparib Plus Abiraterone and Prednisone Improves Outcomes Over Single Agents in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
First-line treatment with the PARP inhibitor olaparib plus the androgen biosynthesis inhibitor abiraterone acetate and the steroid prednisone improved progression-free survival and response rates compared with either treatment alone (ie, olaparib or abiraterone plus prednisone) in patients with...
FDA Grants Accelerated Approval to Zanubrutinib Plus Obinutuzumab for Relapsed or Refractory Follicular Lymphoma
On March 7, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the small-molecule BTK inhibitor zanubrutinib (Brukinsa) in combination with the anti-CD20 monoclonal antibody obinutuzumab for patients with relapsed or refractory follicular lymphoma after two or more lines of ...
FDA Approves Nivolumab in Combination With Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma
On March 6, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. CheckMate 901 Efficacy was evaluated in CheckMate ...
FDA Approves Inotuzumab Ozogamicin for Pediatric Patients With ALL
On March 6, the U.S. Food and Drug Administration (FDA) approved the CD22-targeted antibody-drug conjugate inotuzumab ozogamicin (Besponsa) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Study WI203581...
FDA Approves Denosumab Biosimilars
On March 5, the the U.S. Food and Drug Administration (FDA) approved Jubbonti (denosumab-bbdz, 60 mg/1 mL injection), as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz, 120 mg/1.7 mL [70 mg/mL] injection), as an interchangeable biosimilar to...
FDA Approves Amivantamab-vmjw for EGFR Exon 20 Insertion–Mutated NSCLC
On March 1, the FDA approved the monoclonal bispecific anti–EGFR-MET antibody amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test....
Rapid Guideline Update on Radiotracers for Determining Radioligand Treatment Eligibility in Metastatic Castration-Resistant Prostate Cancer
ASCO has released a guideline rapid recommendation update addressing radiotracers used for prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) diagnostic imaging for selecting patients with metastatic castration-resistant prostate cancer (mCRPC) to receive...
FDA Approves Biweekly Teclistamab Dosing Regimen for Patients With Multiple Myeloma
On February 20, the U.S. Food and Drug Administration (FDA) approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a...
FDA Approves Osimertinib With Chemotherapy for EGFR-Mutated NSCLC
On February 16, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an...
FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have...
FDA Approves Tepotinib for Metastatic NSCLC
On February 15, the U.S. Food and Drug Administration (FDA) granted traditional approval to the kinase inhibitor tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. The agent is...
Steven A. Rosenberg, MD, PhD, Honored With 2024 AACR Award for Lifetime Achievement in Cancer Research
The American Association for Cancer Research (AACR) will award Steven A. Rosenberg, MD, PhD, Fellow of the AACR Academy, with the 2024 AACR Award for Lifetime Achievement in Cancer Research during the AACR Annual Meeting, to be held April 5–10 in San Diego. His award lecture will be presented on...
FDA Approves Irinotecan Liposome as First-Line Treatment of Metastatic Pancreatic Adenocarcinoma
On February 13, the U.S. Food and Drug Administration (FDA) approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. NAPOLI-3 Efficacy was evaluated in NAPOLI-3 (ClinicalTrials.gov identifier...
Antihypertensive 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 ...
