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Showing 151 - 200Dual Use of Cigarettes and E-Cigarettes on Par With Sole Cigarette Use in Terms of Toxic Exposure
Individuals who reported exclusive use of combustible cigarettes as well as those who reported dual use of both cigarettes and e-cigarettes showed similarly high toxicant exposure, according to the results of a study published in Nicotine & Tobacco Research. Both groups of smokers showed higher ...
FDA Approves Bevacizumab Biosimilar
The U.S. Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne), a biosimilar to bevacizumab (Avastin), for intravenous use. Bevacizumab-nwgd is a recombinant humanized monoclonal antibody and a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks...
FDA Approves Nivolumab Plus Ipilimumab for Unresectable or Metastatic HCC
On April 11, 2025, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Efficacy was evaluated in CheckMate-9DW (ClinicalTrials.gov identifier...
FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer
On April 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) with the CTLA-4 inhibitor ipilimumab (Yervoy) for adult and pediatric patients aged 12 years and older with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch...
FDA Expands Indication for Lu-177 Vipivotide Tetraxetan in mCRPC
On March 28, the U.S. Food and Drug Administration (FDA) expanded the indication for lutetium Lu-177 vipivotide tetraxetan (Pluvicto) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen ...
FDA Approves Perioperative Durvalumab for Muscle-Invasive Bladder Cancer
On March 28, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder ...
FDA Approves Cabozantinib for pNET and epNET
Today, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor cabozantinib (Cabometyx) for adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors...
Results Announced From Phase II VERITAC-2 Clinical Trial in Breast Cancer
Arvinas, Inc. and Pfizer Inc. recently announced results from the randomized phase III VERITAC-2 clinical trial (ClinicalTrials.gov identifier NCT05654623) evaluating vepdegestrant monotherapy vs fulvestrant in adults with estrogen receptor–positive, HER2-negative advanced or metastatic breast...
Recent FDA Approvals in Lymphoma and in Rarer Tumors
The U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) in combination with lenalidomide and a rituximab product for adults with relapsed or refractory large B-cell lymphoma (LBCL)—including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising ...
FDA Approves Pembrolizumab for HER2-Positive Gastric or GEJ Cancer Expressing PD-L1
The U.S. Food and Drug Administration (FDA) has granted traditional approval to the PD-L1 inhibitor pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic...
The Real Cost Campaign May Have Prevented Thousands of Youths From Initiating E-Cigarette Use
The U.S. Food and Drug Administration’s (FDA) youth e-cigarette prevention campaign, known as The Real Cost, may have successfully reduced e-cigarette use among youth, according to a recent study published by MacMonegle et al in the American Journal of Preventive Medicine. Background The Real Cost...
Combination Therapy Could Help Overcome Drug Resistance in Patients With KRAS-Mutated NSCLC
Researchers have uncovered a novel combination therapy leveraging the U.S. Food and Drug Administration (FDA)-approved KRAS inhibitor sotorasib and an experimental drug called FGTI-2734, which could improve the efficacy of precision medicine in patients with KRAS-mutated non–small cell lung cancer...
Two Decades of Collaboration: The Accelerating Anticancer Agent Development and Validation (AAADV) Workshop
Over the past 20 years, the investment in research and development of cancer therapies has been unprecedented, and the pace of new drug development has been accelerating. To illustrate this trajectory, the U.S. Food and Drug Administration (FDA) approved 71 treatments for solid cancers in adults...
Discussing Breast Density With Patients Following the FDA Mammography Quality Standards Act Mandate
In JAMA, Lee et al provided a concise, evidence-based summary to help clinicians discuss information regarding breast density and implement shared decision-making with patients following the U.S. Food and Drug Administration (FDA) Mammography Quality Standards Act mandate. Since September 2024,...
Participation in Early Trials May Provide Some Patients With Access to Cancer Drugs Later FDA Approved
Nearly 20% of patients participating in middle-stage cancer drug trials may receive treatments that eventually receive U.S. Food and Drug Administration (FDA) approval, according to a recent study published by Ouimet et al in the Journal of the National Cancer Institute. The findings may have...
Vimseltinib Approved by the FDA for Symptomatic TGCT
The U.S. Food and Drug Administration (FDA) has approved vimseltinib (Romvimza), a kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. MOTION Trial Efficacy was...
eNRGy Trial: Zenocutuzumab for NRG1 Gene Fusion–Positive Solid Tumors
Treatment with the HER2 × HER3 bispecific antibody zenocutuzumab-zbco appeared to be safe and active in patients with advanced NRG1 gene fusion–positive solid tumors, according to results from the registrational phase II eNRGy study published by Schram et al in The New England Journal of Medicine....
Triplet Regimen Demonstrates Benefit in BRAF V600E–Mutant Metastatic Colorectal Cancer
The BRAF inhibitor encorafenib plus the monoclonal antibody cetuximab combined with mFOLFOX (modified folinic acid, fluorouracil, and oxaliplatin) significantly improved overall response in BRAF V600E–mutant metastatic colorectal cancer, according to data presented at the 2025 ASCO Gastrointestinal ...
Jennifer A. Woyach, MD, Named The Ohio State’s Director of Hematology
Jennifer A. Woyach, MD, a hematology cancer expert and researcher who has been with The Ohio State for more than 12 years, has been named Director of the Division of Hematology at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research...
FDA Approves Brentuximab Vedotin With Lenalidomide and Rituximab for Relapsed or Refractory LBCL
The U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL)—including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL ...
Experimental Regimen Demonstrates Benefit in BRAF V600E–Mutant Metastatic Colorectal Cancer
The BRAF inhibitor encorafenib plus the monoclonal antibody cetuximab combined with mFOLFOX (modified folinic acid, fluorouracil, and oxaliplatin) significantly improved overall response in BRAF V600E–mutant metastatic colorectal cancer, according to data presented at the 2025 ASCO Gastrointestinal ...
FDA Approves Mirdametinib for Neurofibromatosis Type 1
On February 11, the U.S. Food and Drug Administration approved mirdametinib (Gomekli), a kinase inhibitor, for adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. ReNeu Trial...
Anticancer Drug Pharmacokinetics May Differ by Sex
Investigators may have uncovered notable pharmacokinetic differences between male and female patients in at least 14 anticancer drugs, according to a recent study published by Delahousse et al in ESMO Open. Background Many cancer drugs have a narrow therapeutic window. As a result, slight...
Using AI to Identify Treatment Options for Castleman Disease
A novel artificial intelligence (AI) tool uncovered an effective treatment for a patient with idiopathic multicentric Castleman’s disease, according to a recent study published by Mumau et al in The New England Journal of Medicine. Background Idiopathic multicentric Castleman’s disease is a rare...
FDA Approves Preparative Regimen for Allogeneic HSCT in Patients With AML or MDS
On January 21, the U.S. Food and Drug Administration (FDA) approved treosulfan (Grafapex), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia ...
CAR T-Cell Therapy Not Linked to Secondary Cancers, Study Finds
Researchers have found no evidence that chimeric antigen receptor (CAR) T-cell therapy caused secondary cancers in the modified T cells, according to a recent study published by Jadlowsky et al in Nature Medicine. Background CAR T-cell therapy is a personalized type of immunotherapy that employs...
FDA Approves First Companion Diagnostic to Identify Patients With Metastatic Breast Cancer Eligible for T-DXd
The U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with hormone receptor (HR)-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with fam-trastuzumab...
Novel BTK and BCL2 Inhibitors Redefine CLL Treatment Across Front-Line and Relapsed Settings
Two pivotal phase III trials presented at the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition mark a significant shift toward chemotherapy-free approaches in chronic lymphocytic leukemia (CLL), offering potentially more effective and tolerable treatment options for both...
Fecal Microbiota Transplantation Following ASCT
Oral fecal microbiota transplantation may be a feasible and safe option to prevent graft-vs-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant (ASCT), according to a recent report published by Reddi et al in Nature Communications. The findings built on ...
FDA Highlights Importance of DPD Deficiency Discussions With Patients Prior to Capecitabine or Fluorouracil Treatment
The U.S. Food and Drug Administration (FDA) has provided a safety announcement to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil related to the risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. Background Fluoropyrimidines are a...
T-DXd Approved by the FDA for Pretreated Patients With HER2-Low or -Ultralow Metastatic Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ...
Novel Combination Targeted Therapies, Chemotherapy in BRAF-Mutated Metastatic Colorectal Cancer
First-line treatment with the targeted therapies encorafenib and cetuximab plus a modified leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) chemotherapy regimen may be effective in patients with BRAF V600E–mutated metastatic colorectal cancer, according to recent findings presented by Kopetz et ...
FDA Approves Datopotamab Deruxtecan-dlnk for Advanced HR-Positive, HER2-Negative Breast Cancer
On January 17, the U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway), a TROP-2–directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC1+, or...
FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma
On January 16, the U.S. Food and Drug Administration (FDA) granted traditional approval to the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem...
FDA Approves Sotorasib With Panitumumab for KRAS G12C–Mutated Colorectal Cancer
On January 16, the U.S. Food and Drug Administration (FDA) approved the KRAS G12C inhibitor sotorasib (Lumakras) with the monoclonal antibody panitumumab (Vectibix) for adult patients with KRAS G12C–mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior ...
FDA Proposes Significant Step to Reduce Nicotine Levels in Cigarettes, Tobacco Products
The U.S. Food and Drug Administration (FDA) issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If the rule is finalized, the United States would be the first...
FDA Grants Orphan Drug Designation to New Agent for Pancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration has granted Orphan Drug designation to the investigational agent ELC-100 for the treatment of pancreatic neuroendocrine tumors, according to a press release from Elicera Therapeutics, the drug developer. ELC-100 is an oncolytic virus–based therapy designed to...
Glucarpidase May Improve Recovery Following Methotrexate-Induced Kidney Toxicity
The drug glucarpidase could serve as an antidote to kidney toxicity in patients receiving the chemotherapy agent methotrexate, according to a recent study published by Gupta et al in Blood. Background As a result of its ability to penetrate the blood-brain barrier, methotrexate is one of the most...
FDA Approves Nivolumab and Hyaluronidase-nvhy for Subcutaneous Injection
On December 27, 2024, the U.S. Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab...
FDA Grants Accelerated Approval to Encorafenib Combination for BRAF V600E–Mutant Metastatic Colorectal Cancer
On December 20, 2024, the U.S. Food and Drug Administration granted accelerated approval to encorafenib (Braftovi) in combination with cetuximab and modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected...
Allison Betof Warner, MD, PhD, on TIL Therapy for Advanced Melanoma: Innovative Clinical Advances in Treatment
Allison Betof Warner, MD, PhD, reviews important clinical research in the treatment of advanced melanoma, including tumor-infiltrating lymphocyte (TIL) therapy, the role of this innovative treatment in advanced melanoma, and relevant data, peer-reviewed literature, and FDA approvals in 2024. She...
Mesenchymal Cell Therapy Approved for Steroid-Refractory Acute GVHD
The U.S. Food and Drug Administration (FDA) recently approved remestemcel-L-rknd (Ryoncil), an allogeneic bone marrow–derived mesenchymal stromal cell therapy for steroid-refractory acute graft-vs-host disease (GVHD) in pediatric patients 2 months of age and older. The application received Orphan...
FDA Approves Ensartinib for ALK- Positive Locally Advanced or Metastatic NSCLC
On December 18, 2024, the U.S. Food and Drug Administration (FDA) approved the anaplastic lymphoma kinase (ALK) inhibitor ensartinib (Ensacove) for adults with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. For full...
Generic Platinum Chemotherapy Shortages May Not Have Increased Mortality
During a shortage of the generic platinum chemotherapy drugs cisplatin and carboplatin that began in early 2023, investigators found no difference in mortality rates among patients with advanced cancer compared with the previous year, according to a recent study published by Reibel et al in the...
Cosibelimab-ipdl Approved by FDA for Treatment of Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
The U.S. Food and Drug Administration (FDA) approved cosibelimab-ipdl (Unloxcyt), a PD-L1–blocking antibody, for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation therapy. The approval was granted on December 13,...
Accelerated Approval Granted to Zanidatamab-hrii for HER2-Positive Biliary Tract Cancer
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also...
Oral Liquid Imatinib Approved by the FDA in Leukemia
The U.S. Food and Drug Administration (FDA) recently has approved an oral solution of the tyrosine kinase inhibitor, imatinib mesylate, called Imkeldi, to treat certain types of leukemia and other cancers. The new solution is an advanced liquid formulation of imatinib designed to provide dosing...
The Future of Cancer Care, Part 2
The soaring number of cancer survivors since the National Cancer Act of 1971 was enacted into law provides a snapshot of the profound progress made against cancer over the past half-century: 3 million survivors in the 1970s,1 compared to more than 18 million today, and that number is expected to...
FDA Approves Durvalumab for Limited-Stage Small Cell Lung Cancer
On December 4, 2024, the U.S. Food and Drug Administration approved durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Efficacy was evaluated in ADRIATIC...
FDA Grants Approval to New Bispecific Antibody for NSCLC and Pancreatic Adenocarcinoma
On December 4, 2024, the U.S. Food and Drug Administration granted accelerated approval to the HER2 × HER3 bispecific antibody zenocutuzumab-zbco (Bizengri) for adults with the following types of lung and pancreatic cancers: advanced, unresectable, or metastatic non–small cell lung cancer (NSCLC)...
