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Showing 101 - 150Lisaftoclax Regimens Effective in Plasma Cell Disorders
Lisaftoclax, an investigational BCL2 inhibitor, in combination with pomalidomide/dexamethasone (Pd) or daratumumab/lenalidomide/dexamethasone (DRd) led to improved outcomes for patients with relapsed or refractory multiple myeloma and for patients with AL amyloidosis, according to findings from a...
EHA Publishes Guidelines for LBCL and Multiple Myeloma
The European Hematology Association (EHA) has published two new sets of clinical practice guidelines, including its first dedicated guidelines for large B-cell lymphoma (LBCL), which was published in HemaSphere, as well as an updated set of guidelines in collaboration with the European Myeloma...
PD-1 Inhibitor Approved for Adjuvant Treatment of CSCC
On October 8, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation therapy. C-POST Efficacy was evaluated in C-POST (ClinicalTrials.gov ...
FDA Approves Combination Regimen for Extensive-Stage SCLC
On October 2, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for maintenance treatment of adults with extensive-stage small cell lung cancer (SCLC) whose disease...
Prostate Cancer: Radiopharmaceutical Plus SBRT Delays Progression in Patients With Limited Metastatic Disease
A new clinical trial found that people with a limited number of metastases from recurrent prostate cancer lived significantly longer without disease progression when they received a radiopharmaceutical drug before targeted radiation compared with radiation alone. The phase II LUNAR trial is the...
FDA Removes Vandetanib REMS Program
On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency. Vandetanib is a tyrosine kinase inhibitor targeting VEGFR, EGFR, and RET from manufacturer Sanofi (formerly ...
Advanced or Metastatic Breast Cancer: FDA Approves Imlunestrant for ER-Positive, HER2-Negative, ESR1-Mutated Disease
The U.S. Food and Drug Administration (FDA) has approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, HER2-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression after at least one line of...
HPV Self-Sampling Collection Test Improved Cervical Cancer Screening Rates Among Asian American Women
Studies have shown that human papillomavirus (HPV) infection—especially with high-risk variants such as HPV16 and HPV18—is the primary cause of cervical cancer, accounting for about 95% of all cases. Although cervical cancer screening through Pap smear tests can detect the presence of precancerous...
AACR Cancer Progress Report 2025 Highlights Breakthroughs in Blood Cancers and How NIH Funding Uncertainty Threatens Advances
The 15th edition of the annual AACR Cancer Progress Report presents a mixed picture of the major advances in cancer care over the past year, including the approval of 20 new anticancer drugs, juxtaposed against the continuing rise in early-onset cancers and disparities in care as well as the...
FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection
The U.S. Food and Drug Administration (FDA) approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda). Efficacy and...
New Approvals for Thrombocytopenia, Lung Cancer, Brain Cancer, and Multiple Myeloma
BTK Inhibitor for Chronic Immune Thrombocytopenia: On September 2, 2025, the U.S. Food and Drug Administration (FDA) approved the Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib (Wayrilz) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an...
Contemporary Management of Chronic Myeloid Leukemia, According to Hagop M. Kantarjian, MD, FASCO
Chronic myeloid leukemia (CML) is one of the success stories among the hematologic malignancies. Now, with decades of data informing its management, it is time to change some of the practices to which clinicians have become accustomed, said leukemia expert Hagop M. Kantarjian, MD, FASCO, Professor...
New Subcutaneous Amivantamab Combo Dosing Schedule Shows Promising Safety and Efficacy in EGFR-Positive NSCLC
The combination of subcutaneous amivantamab-vmjw every 4 weeks plus daily oral lazertinib led to a high response rate in patients with previously untreated EGFR-mutated advanced non–small cell lung cancer (NSCLC), according to findings from an analysis of cohort 5 of the PALOMA-2 trial presented at ...
FDA Approves Kinase Inhibitor for Pediatric Patients With NF1
The U.S. Food and Drug Administration (FDA) has approved selumetinib (Koselugo) granules and capsules for pediatric patients aged 1 year and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA previously approved selumetinib capsules for...
FDA Approves Gemcitabine Intravesical System for Non–Muscle-Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has approved the gemcitabine intravesical system (Inlexzo) for adults with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. The gemcitabine intravesical system is...
FDA’s OCE Invites External Research Questions to Advance Science, Benefit Patients
The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) invites academic and patient advocate researchers to propose research questions for Project Collaborate, a unique crowdsourcing initiative running through September 26. This represents a rare opportunity to leverage...
Observation Outperforms Adjuvant Crizotinib for Resected ALK-Positive NSCLC
Adjuvant treatment with the first-generation ALK inhibitor crizotinib failed to improve disease-free survival outcomes over observation for patients with surgically resected ALK-positive non–small cell lung cancer (NSCLC), according to findings from the phase III E4512 trial presented at the...
FDA Approves BTK Inhibitor for ITP
The U.S. Food and Drug Administration (FDA) has approved rilzabrutinib (Wayrilz), a Bruton’s tyrosine kinase (BTK) inhibitor, for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA ...
Understanding Accelerated Aging in Survivors of Childhood Cancers
Each year in the United States, nearly 16,000 children and adolescents between the ages of birth and 19 are diagnosed with cancer.1 And although survival rates have greatly improved for many types of childhood cancers, with more than 8 in 10 children and adolescents surviving at least 5 years after ...
Smoldering Multiple Myeloma: How the Guidance Is Changing
Clinical trials have sought to determine the benefit of treating the precursors of multiple myeloma, but as the phenotypes and genomics of this entity are becoming better delineated, the wisdom of early intervention has remained confusing for clinicians. At the 2025 Debates and Didactics in...
Treatment Rechallenge After Interstitial Lung Disease Related to T-DXd: Is It Safe?
Rechallenge with the HER2-directed antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) after grade 1 interstitial lung disease (ILD) appeared to be safe in a diverse real-world population, including many patients with breast cancer, as presented during the 2025 ASCO Annual Meeting.1 The ...
New Report Supports Overhaul of Cancer Drug Dosing
A new study calls for a paradigm shift in how cancer drug dosages are determined, concluding that the long-standing practice of using the “maximum tolerated dose” (MTD) may be outdated, harmful to patients, and ill-suited for modern cancer therapies. “The Totality of the Evidence: Optimizing Dosage ...
Emerging PD-1 Inhibitor Plus Chemotherapy Shows Efficacy in Second-Line Classical Hodgkin Lymphoma
The addition of the PD-1 inhibitor sintilimab to ICE (ifosfamide, carboplatin, and etoposide) chemotherapy appeared to significantly improve the complete remission rate and showed a trend toward improved progression-free survival in second-line classical Hodgkin lymphoma, according to Yuankai Shi,...
Are Postmastectomy Implant-Based Breast Reconstructions Associated With Lymphomas of the Breast?
The results of a cohort study published in JAMA Network Open revealed an epidemiologic association between postmastectomy implant-based breast reconstruction for any breast tumor and both B- and T-cell non-Hodgkin lymphomas of the breast. According to Kinslow et al, this includes diffuse large...
Kinase Inhibitor Approved for Nonsquamous NSCLC With HER2 TKD–Activating Mutations
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD)–activating mutations, as...
Protease 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...
