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Showing 151 - 200SWOG S2302 Pragmatica-Lung Study Design Still Significant Even With Negative Results in Advanced NSCLC
Although the SWOG S2302 Pragmatica-Lung trial did not achieve its primary endpoint of improved overall survival with the combination of ramucirumab and pembrolizumab compared with standard-of-care treatments for patients with stage IV or recurrent non–small cell lung cancer (NSCLC) who previously...
Niraparib Plus Abiraterone in HRR-Mutant Metastatic Castration-Sensitive Prostate Cancer
Results from the international phase III AMPLITUDE clinical trial found that adding niraparib to abiraterone acetate plus prednisone (AAP) may help to slow cancer growth for people with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene...
Menopause Medication May Help to Prevent Invasive Breast Cancer, Study Finds
A drug already approved by the FDA to treat menopause symptoms may also help to prevent invasive breast cancer, according to recent findings from a clinical trial led by Northwestern Medicine. The research was presented at the 2025 ASCO Annual Meeting (Abstract 512). Study Details The multicenter,...
HER3-Targeted Antibody-Drug Conjugate for Treatment-Resistant Solid Tumors
Results from an international clinical trial demonstrated that DB-1310, a new antibody-drug conjugate, is showing early signs of effectiveness in patients with advanced solid tumors that have not responded to standard treatments, particularly those with EGFR-mutant non–small cell lung cancer...
ASCO 2025: Switching to Camizestrant After Detection of an ESR1 Mutation Improves Progression-Free Survival for Some Patients With Advanced Breast Cancer
Switching to treatment with camizestrant if an ESR1 mutation is detected during first-line treatment can help slow cancer growth for patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to findings from the phase III SERENA-6 clinical trial. The research is...
Encorafenib/Cetuximab Plus Chemotherapy Improves Survival in BRAF V600E–Mutant Metastatic Colorectal Cancer
Results from an international phase III study showed that the targeted therapy combination of encorafenib and cetuximab with mFOLFOX6 (leucovorin, fluorouracil, and oxaliplatin) chemotherapy may help patients with BRAF V600E–mutant metastatic colorectal cancer live longer. After early results from...
What Is the Value in Cost and Lives Saved of Cancer Screening and Prevention?
Several recent studies have shown the value of cancer screening in reducing the number of deaths from the disease. One study using computer modeling to estimate the number of cancer-related deaths that could be averted by increasing the use of U.S. Preventive Services Task Force (USPSTF)...
Inavolisib-Based Regimen in PIK3CA-Mutated, HR-Positive, HER2-Negative Advanced Breast Cancer
New findings from the phase III INAVO120 trial showed that adding inavolisib to palbociclib and fulvestrant may help extend survival and delay the time until treatment with chemotherapy in previously treated patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The...
Cellular Therapies Show Sustained Promise in Hematologic Malignancies, but Access Remains Uneven
Cellular therapies such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocyte therapy are transforming outcomes for patients with cancer, particularly in the relapsed or refractory setting. “We’re seeing outstanding response rates in patients with B-cell malignancies...
Retifanlimab-dlwr Approved for Anal Cancer
On May 15, the U.S. Food and Drug Administration (FDA) approved retifanlimab-dlwr (Zynyz), a PD-1–blocking monoclonal antibody, with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC)....
FDA Approves Therapy for NSCLC With High c-Met Protein Overexpression
On May 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis), a c-Met–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, nonsquamous, non–small cell lung cancer (NSCLC) with high c-Met ...
FDA Approves First Oral Therapy for Pheochromocytoma and Paraganglioma
On May 14, the U.S. Food and Drug Administration approved the oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (Welireg) for patients aged 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA ...
NCCN Clinical Practice Guidelines in Oncology: 2025 Updates
The National Comprehensive Cancer Network (NCCN) released its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Today, guidelines are available for more than 60 tumor types, subtypes, and related topics. During the NCCN’s 30th Annual...
FDA OCE Announces Project Interface Outreach Initiative
The Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA) has launched Project Interface to advance engagement and outreach to patients with cancer, advocacy organizations, and oncology experts. Its mission is to protect, promote, and advance public health by...
FDA Approves At-Home Self-Collection Device for Cervical Cancer Screening
Teal Health announced the U.S. Food and Drug Administration’s (FDA) approval of the Teal Wand™, an at-home vaginal sample self-collection device for cervical cancer screening in the United States. The Teal Wand is a prescription device that will soon be available at getteal.com for individuals aged ...
FDA Approves Doublet for KRAS-Mutated, Recurrent, Low-Grade Serous Ovarian Cancer
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of the dual RAF/MEK inhibitor avutometinib and the FAK inhibitor defactinib (Avmapki Fakzynja Co-pack) for adults with KRAS-mutated, recurrent, low-grade serous ovarian cancer (LGSOC) who have...
Patterns in Oncology Drug Use After Accelerated Approval Is Withdrawn
The accelerated approval program of the U.S. Food and Drug Administration (FDA) allows certain medications to be marketed if they are indicated for serious disease and there has been preliminary evidence of the drug’s efficacy. Pharmaceutical companies must then conduct postapproval trials to...
Rakesh K. Jain, PhD, FAACR, Honored With 2025 AACR Award for Lifetime Achievement in Cancer Research
The 2025 AACR Award for Lifetime Achievement in Cancer Research was presented to Rakesh K. Jain, PhD, FAACR, during the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago. This award honors individuals who have made significant fundamental contributions to cancer...
Off-the-Shelf Natural Killer CAR T-Cell Therapy Shows Efficacy in Small Study of Relapsed or Refractory Blood Cancers
The U.S. Food and Drug Administration (FDA) approved the first chimeric antigen receptor (CAR) T-cell therapy in 2017 to treat children with acute lymphoblastic leukemia.1 Over the past decade, other CAR T-cell therapies have been FDA approved to treat adults with blood cancers, including...
Richard Pazdur, MD, Honored With 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine
During the 2025 American Association for Cancer Research (AACR) Annual Meeting, Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), accepted the 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine...
AACR 2025: Oral HER2-Targeted Therapy for Advanced HER2-Mutated Lung Cancer
The novel HER2-targeted tyrosine kinase inhibitor zongertinib elicited durable responses in patients with advanced, previously treated non–small cell lung cancer (NSCLC) that harbored a HER2 mutation, according to the preliminary results of the early-phase Beamion LUNG-1 trial. These findings were...
AACR 2025: Off-the-Shelf Natural Killer CAR Therapy Active in Hematologic Malignancies
The U.S. Food and Drug Administration (FDA) approved the first chimeric antigen receptor (CAR) T-cell therapy in 2017 to treat children with acute lymphoblastic leukemia. Over the past decade, other CAR T-cell therapies have been FDA-approved to treat adults with blood cancers, including...
FDA Approves Anti–PD-1 Antibody for Nasopharyngeal Cancer
The U.S. Food and Drug Administration (FDA) has approved the humanized IgG1 monoclonal anti–PD-1 antibody penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma (NPC). The FDA also...
Combination Immunotherapy Approved for Unresectable or Metastatic Hepatocellular Carcinoma
On April 11, 2025, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma. (See here for details on approval of this combination immunotherapy for colorectal...
Cabozantinib Approved for Treatment of Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) recently 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...
Dual 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 ...
