Search Results
Your search for ,Fda matches 3728 pages
Showing 101 - 150Protease Activator Approved by the FDA for Diffuse Midline Glioma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to dordaviprone (Modeyso) a protease activator, for adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation who have progressive disease after prior therapy. This...
Pediatric Gliomas: Early Research on Targeted Therapies
A collaborative study between Dana-Farber Cancer Institute and the Broad Institute found that 8.9% of children with glioma, the most common type of pediatric brain tumor, have alterations in the fibroblast growth factor receptor (FGFR) family of proteins, and these gliomas may be sensitive to...
Study Shows Increased Prescribing After Accelerated vs Regular Approval of Cancer Drugs
A cross-sectional study of cancer drug indications granted accelerated approval, which was published in JAMA Network Open, found that prescribing increased more after accelerated approval than after conversion to regular approval. Parikh et al also noted that off-label prescribing after accelerated ...
AI Enhances Detection of Missed Breast Cancers on Screening Tomosynthesis
A U.S. Food and Drug Administration (FDA)–cleared artificial intelligence (AI) algorithm was able to detect and correctly localize almost one-third of interval breast cancers in a retrospective evaluation of screening digital breast tomosynthesis (DBT), findings published in Radiology showed. The...
The Inflation Reduction Act and Ibrutinib
In August 2024, the Centers for Medicare & Medicaid Services (CMS) announced a negotiated price for the Bruton’s tyrosine kinase inhibitor ibrutinib that is 38% lower than the manufacturer’s list price. This new price will go into effect in January 2026. Negotiations began following passage...
Outcomes With Perioperative Immunotherapy in Resectable NSCLC
In a retrospective cohort study reported in JAMA Network Open, Desai et al examined survival outcomes with the addition of immunotherapy to neoadjuvant or adjuvant chemotherapy in patients with resectable non–small cell lung cancer (NSCLC). Study Details The study involved data from the Flatiron...
Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable HCC
The U.S. Food and Drug Administration (FDA) has approved SIR-Spheres Y-90 resin microspheres, manufactured by Sirtex, for the treatment of unresectable hepatocellular carcinoma (HCC). With this approval, these microspheres become the only radioembolization therapy approved for the treatment of both ...
Survival Disparities Rise in Patients With Advanced Cancer Depending on Whether They Have Insurance to Cover Immune Checkpoint Inhibitors
A study led by researchers at the American Cancer Society examining the association between the introduction of immune checkpoint inhibitors (ICIs) and changes in survival disparities by health insurance coverage among patients with newly diagnosed stage IV melanoma, non–small cell lung cancer...
Preclinical Leukemia Chip Platform Improves Evaluation of CAR T-Cell Therapies
Investigators have bioengineered an organotypic immunocompetent chip—a laboratory device that combines the physical structure of human leukemia bone marrow and a functioning immune system—to empower real-time spatiotemporal monitoring of CAR-T cell functionality for leukemias. The preclinical...
FDA Grants Accelerated Approval to Sunvozertinib for Metastatic NSCLC With EGFR Exon 20 Insertion Mutations
On July 2, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sunvozertinib (Zegfrovy), a selective EGFR tyrosine kinase inhibitor, for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an...
FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma
On July 2, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of...
Erika Hamilton, MD, on Oral SERDs in Breast Cancer: State of the Science
Erika Hamilton, MD, Director, Breast Cancer Research at Sarah Cannon Research Institute, provides a look at “where we stand in 2025” in the field of oral selective estrogen receptor degraders (SERDs) for patients with estrogen receptor–positive, HER2-negative breast cancer. She discusses the first...
Updated Results Confirm Benefit of Combination Regimen in BRAFV600E–Mutated Metastatic Colorectal Cancer
Patients with previously untreated BRAF V600E–mutated metastatic colorectal cancer who receive the BRAF inhibitor encorafenib and the EGFR inhibitor cetuximab plus mFOLFOX6 (modified leucovorin, fluorouracil, and oxaliplatin) vs the current standard of care (chemotherapy ± bevacizumab) may live...
FDA Approves Label Expansion for Agent Used in Patient Selection for Pre-Taxane Radioligand Therapy
The U.S. Food and Drug Administration (FDA) has approved a label expansion of a kit for the preparation of gallium Ga-68 gozetotide for injection (Illuccix) to include patient selection for radioligand therapy in the pre-taxane setting. The update applies to the imaging agent’s third indication,...
Early ESR1 Mutation Detection and Therapy Switch in Advanced Hormone Receptor–Positive, HER2-Negative Breast Cancer
Early detection of an ESR1 mutation, leading to a switch of endocrine therapy, led to an almost doubling in progression-free survival in the SERENA-6 trial, the global registrational study in patients with metastatic breast cancer for the investigational oral selective estrogen receptor degrader...
FDA Grants Accelerated Approval to Datopotamab Deruxtecan-dlnk for EGFR-Mutated NSCLC
On June 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway), an antibody-drug conjugate that targets trophoblast cell surface antigen 2 (TROP2), for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer...
FDA Approves CD19-Directed Antibody–Based Regimen for Follicular Lymphoma
On June 18, the U.S. Food and Drug Administration approved tafasitamab-cxix (Monjuvi), a CD19-directed cytolytic antibody, with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. inMIND Trial Efficacy was evaluated in inMIND (ClinicalTrials.gov identifier...
BRCA Mutations Could Increase Risk of Rare Lymphoma Among Women Who Received Textured Breast Implants During Breast Cancer Treatment
The risk of developing breast implant–associated anaplastic large-cell lymphoma (ALCL) could be higher among women with breast cancer and BRCA1 or BRCA2 mutations who received textured breast implants as part of their postmastectomy reconstructive surgery compared with patients lacking the genetic...
FDA Approves Neoadjuvant and Adjuvant Pembrolizumab for Resectable, Locally Advanced Head and Neck Cancer
Yesterday, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [combined positive score (CPS) ≥ 1] as determined by an FDA-approved test, as a single agent ...
FDA Approves Mitomycin Intravesical Solution for Recurrent Low-Grade Intermediate-Risk Non–Muscle-Invasive Bladder Cancer
On June 12, 2025, the U.S. Food and Drug Administration (FDA) approved mitomycin intravesical solution (Zusduri) for adult patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer. Mitomycin intravesical solution is a reverse thermal hydrogel formulation of mitomycin...
FDA Approves Taletrectinib for ROS1-Positive Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved the oral next-generation ROS1 tyrosine kinase inhibitor (TKI) talectrectinib (Ibtrozi) for the treatment of adults with ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC). Investigators reported that the agent has ...
I Was an N-of-1 in a CAR T-Cell Therapy Trial for Ovarian Cancer
More than a decade after I was diagnosed with late-stage ovarian cancer, a phase I clinical trial at Moffitt Cancer Center and Research Institute in Tampa, Florida, investigating a dose of a novel follicle-stimulating hormone receptor (FSHR)-targeting chimeric antigen receptor (CAR) T-cell therapy...
Retifanlimab-dlwr Approved for Anal Cancer in Combination With Carboplatin Plus Paclitaxel and as a Single Agent
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. The FDA also...
Study Shows Potential Benefits of AI-Assisted Classification in HER2-Low and HER2-Ultralow Breast Cancer
With the approval of HER2-targeted antibody-drug conjugate options for treating patients with breast cancer across different HER2 expression levels, accurate assessment of HER2 expression has become more important than ever. And a recent study may provide a solution to the challenge of accurate...
FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
On June 3, 2025, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). The oral androgen receptor inhibitor had previously been approved by the FDA in combination with docetaxel for mCSPC. Efficacy...
SWOG 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...
