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Showing 151 - 200HER2-Positive Early Breast Cancer: Trastuzumab Deruxtecan Moves Into Earlier Clinical Settings
Two pivotal studies of fam-trastuzumab deruxtecan-nxki (T-DXd) in early HER2-positive breast cancer suggest this antibody-drug conjugate (targeting the HER2 protein) may be moving into the curative setting after having shown benefit in metastatic disease in multiple previous trials. The new...
Perioperative Immunotherapy Regimen Improves Outcomes in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A perioperative regimen of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab significantly improved outcomes vs radical cystectomy alone in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy. Results...
Traditional Approval Granted to Tarlatamab-dlle for Extensive-Stage SCLC
On November 19, the U.S. Food and Drug Administration (FDA) granted traditional approval to tarlatamab-dlle (Imdelltra), a DLL3-targeting bispecific T-cell engager, for adults with extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy....
FDA Grants Accelerated Approval to Sevabertinib for Nonsquamous NSCLC
On November 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adults with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD) activating...
Newly Diagnosed AL Amyloidosis: FDA Grants Traditional Approval to Regimen
On November 19, the U.S. Food and Drug Administration (FDA) granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. The FDA granted accelerated approval to the...
FDA Approves Selumetinib for Adults With NF1 With Symptomatic, Inoperable Plexiform Neurofibromas
On November 19, the U.S. Food and Drug Administration (FDA) approved selumetinib (Koselugo), a MEK inhibitor, for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). In September 2025, the FDA approved selumetinib capsules and granules for...
FDA Approves Epcoritamab for Two Follicular Lymphoma Indications
On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp (Epkinly), a bispecific CD20-directed CD3 T-cell engager, in combination with lenalidomide and rituximab for the treatment of patients with relapsed or refractory follicular lymphoma. In addition, the FDA...
Sacituzumab Tirumotecan Improves Survival in EGFR-Mutated NSCLC After Tyrosine Kinase Inhibitor Failure
Sacituzumab tirumotecan, a novel TROP2 antibody-drug conjugate, was found to significantly improve both progression-free and overall survival compared with platinum-based chemotherapy in patients with EGFR-mutated non–small cell lung cancer (NSCLC) who had experienced disease progression following...
FDA Approves Ziftomenib for NPM1-Positive AML
On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved ziftomenib (Komzifti), a menin inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options...
Advanced Epithelial Ovarian Cancer: First-Line PARP Inhibitor Maintenance Therapy and Survival
A systematic review and meta-analysis published in JAMA Network Open found first-line PARP inhibitor maintenance after platinum-based chemotherapy was linked to improved progression-free survival across multiple patient populations with advanced-stage epithelial ovarian cancer. However, according...
Exercise Training Improves Strength and Quality of Life for Patients With Metastatic Breast Cancer
Supervised aerobic and resistance exercise can improve the physical performance and strength of patients living with metastatic breast cancer, according to new data from the PREFERABLE-EFFECT study that was presented by Anne May, PhD, during the Advanced Breast Cancer Eighth International Consensus ...
Immunotherapy Combination Active in Patients With Large B-Cell Lymphoma Who Are Not Eligible for Autologous Stem Cell Transplant
In the global phase III SUNMO trial, the combination of a bispecific antibody and an antibody-drug conjugate was compared with rituximab plus gemcitabine and oxaliplatin (GemOx) in the treatment of patients with relapsed or refractory large B-cell lymphoma (LBCL) who were ineligible for autologous...
Safety and Benefit of Radiation Therapy for High-Risk Muscle-Invasive Bladder Cancer
Following cystectomy, patients with muscle-invasive bladder cancer at high risk for recurrence may safely be treated with radiotherapy and may achieve an improvement in locoregional control compared with observation. These findings, which come from the phase III BART trial presented in a plenary...
Adding an Investigational Monoclonal Antibody to Ibrutinib May Allow Patients With CLL to Discontinue Daily Treatment
Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia in the Western hemisphere, accounting for between 25% and 35% of all leukemias in the United States. According to the American Cancer Society, nearly 24,000 new cases of CLL will be diagnosed in the United States this year,...
FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma. Efficacy of daratumumab and hyaluronidase as monotherapy vs active monitoring was evaluated in AQUILA, an open-label,...
Final Overall Survival Confirms Benefit of Durvalumab Plus FLOT in Resectable Gastric and Gastroesophageal Junction Adenocarcinomas
The addition of the PD-L1–targeting monoclonal antibody durvalumab to conventional perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) resulted in a statistically significant and clinically meaningful improvement in overall survival, with benefit seen...
Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: 5-Year Follow-up of ZUMA-5
As reported in the Journal of Clinical Oncology by Neelapu et al, the 5-year follow-up of the phase II ZUMA-5 trial has shown sustained responses with axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory indolent non-Hodgkin lymphoma. Study Details In the single-arm,...
Pembrolizumab Plus Weekly Paclitaxel Improves Survival Outcomes in Platinum-Resistant Recurrent Ovarian Cancer
The addition of the PD-1 inhibitor pembrolizumab to weekly paclitaxel, with or without the VEGFA-targeted bevacizumab, significantly improved progression-free survival and overall survival in patients with platinum-resistant recurrent ovarian cancer, in the randomized, double-blind, phase III...
Zenocutuzumab Potential Explored in NRG1-Positive Cholangiocarcinoma
Zenocutuzumab-zbco yielded clinical activity in more than one-third of patients with cholangiocarcinoma and an NRG1 fusion, according to findings from the phase II eNRGy trial presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Abstract ...
HER2-Positive Early Breast Cancer: Trastuzumab Deruxtecan Moves Into Earlier Clinical Settings
Two pivotal studies of fam-trastuzumab deruxtecan-nxki (T-DXd) in early HER2-positive breast cancer suggest this antibody-drug conjugate (targeting the HER2 protein) may be moving into the curative setting after having shown benefit in metastatic disease in multiple previous trials. The new...
Perioperative Immunotherapy Regimen Improves Outcomes in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A perioperative regimen of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab significantly improved outcomes vs radical cystectomy alone in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy. Results...
Revumenib Approved by FDA for NPM1-Positive AML
On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved revumenib (Revuforj), a menin inhibitor, for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation, in adult and pediatric patients 1 year and older who have no...
FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma
On October 23, 2025, the U.S. Food and Drug Administration (FDA) approved belantamab mafodotin-blmf (Blenrep), a B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate, in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or...
PD-L1 Plus CTLA-4 Inhibition for Renal Cell Carcinoma Following Resection: RAMPART
Combination immunotherapy significantly improved disease-free survival after surgery in patients with primary renal cell carcinoma (RCC), according to results from the phase III RAMPART trial. These findings were presented at the European Society for Medical Oncology (ESMO) Congress 2025 by James...
Local Consolidative Therapy Enhances Outcomes With Osimertinib in EGFR-Mutant NSCLC
Osimertinib in combination with local consolidative therapy of radiation and/or surgery led to a significant extension of progression-free survival for patients with EGFR-mutant metastatic non–small cell lung cancer (NSCLC), according to findings from the phase II NorthStar trial presented at the...
Biomarker-Driven Apalutamide Therapy for Patients With Recurrent Prostate Cancer
Use of PAM50 subtyping allowed clinicians to determine which patients with recurrent prostate cancer were most likely to benefit from the addition of apalutamide hormonal therapy to salvage radiotherapy, according to findings from the phase II BALANCE trial (NRG GU006). These results were presented ...
Postsurgical ctDNA Testing in Stage III Colon Cancer for Treatment De-escalation
Circulating tumor DNA (ctDNA) was found to be a strong prognostic classifier for patients with stage III colon cancer following surgery, according to findings from the phase II/III DYNAMIC-III trial. Findings from the study presented at the European Society for Medical Oncology (ESMO) Congress 2025 ...
How Embedding an Algorithm-Based Referral System Into Electronic Health Records Is Increasing Access to Palliative Care
Despite numerous studies showing the benefits of integrating palliative care in both the early- and advanced-stage cancer settings,1 palliative care remains underutilized for most patients with cancer. A recent study by the American Cancer Society found that only 10% of Medicare beneficiaries with...
New Approvals in Breast and Bladder Cancers
Here are brief reports on three oncology approvals by the U.S. Food and Drug Administration (FDA) in September 2025: • Estrogen Receptor Antagonist in Advanced or Metastatic Breast Cancer: The FDA has approved imlunestrant (Inluriyo), an estrogen receptor antagonist, for adults with estrogen...
Adjuvant Pembrolizumab in Merkel Cell Carcinoma
A new clinical trial from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) presented at the European Society for Medical Oncology (ESMO) 2025 Congress found that adjuvant therapy with the PD-1 inhibitor pembrolizumab appeared to reduce the risk of distant metastases for an aggressive form of skin...
Final FLAURA2 Analysis Confirms First-Line Benefit of Osimertinib/Chemotherapy in EGFR-Positive NSCLC
The combination of osimertinib plus chemotherapy led to a median overall survival of 47.5 months compared with 37.6 months with osimertinib monotherapy in patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC) who had not received prior treatment for advanced disease, according to...
ADC Improves Outcomes for Patients With Advanced TNBC Ineligible for Immunotherapy
Patients with an aggressive type of breast cancer who are not candidates for immune checkpoint inhibitor therapy showed significantly improved progression-free survival when treated with the antibody-drug conjugate (ADC) sacituzumab govitecan-hziy compared with standard chemotherapy. These...
RCC: Lenvatinib/Everolimus Extends PFS After PD-1 Inhibition
The combination of lenvatinib and everolimus significantly improved progression-free survival compared with cabozantinib in patients with metastatic clear cell renal cell carcinoma (ccRCC) that has progressed on PD-1 immune checkpoint inhibitors, according to findings from the phase II LenCabo...
Cutaneous T-Cell Lymphoma: Use of Durvalumab Alone or With Lenalidomide Under Study in Phase II Trial
In a randomized phase II trial, Christiane Querfeld, MD, PhD, and colleagues investigated the effects of a PD-L1–blocking strategy for targeting both the innate and adaptive immune systems in cutaneous T-cell lymphoma (CTCL). At the 2025 Society of Hematologic Oncology (SOHO) Annual Meeting,1 Dr....
FANSS: Should Lung Cancer Screening Guidelines Be Expanded to Include Female Asian Nonsmokers?
The results of the multicenter Female Asian Nonsmoker Screening Study (FANSS) suggest that low-dose CT screening is feasible and has value for early lung cancer detection in the historically underserved demographic of Asian women with no history of smoking. These data from the largest United...
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 ...
Improved Outcomes Reported With Second-Line Regimen of Ivonescimab Plus Chemotherapy in NSCLC
In the phase III HARMONi trial, when ivonescimab was given with carboplatin plus pemetrexed, vs the chemotherapy regimen alone, after a third-generation tyrosine kinase inhibitor, patients with EGFR-mutated non–small cell lung cancer (NSCLC) had a significant delay in disease progression.1...
Pulsed Low-Dose–Rate Chemoradiation Reduces Severe Esophagitis in Esophageal Cancer and NSCLC
Chemoradiation with a pulsed low-dose–rate technique led to lower-than-usual rates of severe esophagitis without compromising efficacy in patients with esophageal and non–small cell lung cancer (NSCLC), according to findings from a single-arm phase I study presented as a poster during the American...
Breast Volume Preservation Comparable After Five-Fraction Whole- or Partial-Breast Radiotherapy
No significant differences were observed in breast volume loss between five-fraction whole-breast and partial-breast radiation therapy in patients with breast cancer who underwent prior partial mastectomy, according to the results of a study presented in a poster during the American Society for...
Immunotherapy Addition Yields QOL Benefits in Limited-Stage Small Cell Lung Cancer
Clinically meaningful improvements in longer-term quality of life were achieved with the addition of atezolizumab immunotherapy to chemoradiation in patients with limited-stage small cell lung cancer (LS-SCLC), according to patient-reported outcome findings from the NRG LU005 trial presented during ...
Dose-Intensified Proton Therapy for Newly Diagnosed Glioblastoma
Dose intensification of proton radiation therapy led to improved overall survival for patients with newly diagnosed glioblastoma, according to findings from a cohort of the phase II NRG-BN001 trial, which were presented as late-breaking research during the 2025 American Society for Radiation...
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...
Variation in PSA Levels in Annual Testing Among Individuals Without a Prostate Cancer Diagnosis
In a study reported in JAMA Oncology,1 Nicholas A. Pickersgill, MD, of the Department of Surgery (Urology Service) at Memorial Sloan Kettering Cancer Center, New York, and colleagues found that individuals without prostate cancer undergoing annual prostate-specific antigen (PSA) testing often...
Intermediate-Risk Prostate Cancer: Shorter Radiation Improves Patient Experience, But Not Disease Control
For patients with intermediate-risk, localized prostate cancer, radiation therapy delivered in five sessions reduced patient-reported side effects compared to longer courses of radiation, according to results of a large, randomized phase III trial. Patients treated with stereotactic body radiation...
Oropharyngeal Cancer Quality-of-Life Outcomes: IMRT vs Proton-Beam Therapy
A new phase III clinical trial has found that intensity-modulated radiation therapy (IMRT) and proton-beam therapy resulted in similar quality-of-life outcomes and low rates of side effects for people with locally advanced oropharyngeal cancer. The TORPEdO trial, a randomized study conducted across ...
SABR May Be Comparable to Surgery for Early-Stage NSCLC
Stereotactic radiation therapy (SABR) was found to be noninferior to surgical resection in terms of overall survival for patients with early-stage non–small cell lung cancer (NSCLC), according to 10-year results from the STARS trial presented at the American Society for Radiation Oncology (ASTRO)...
Adjuvant Radiation Therapy Safe and Beneficial in Locally Advanced Muscle-Invasive Bladder Cancer
Adjuvant radiation therapy following radical cystectomy and chemotherapy was found to be safe and efficacious for patients with locally advanced muscle-invasive bladder cancer, according to findings from the phase III randomized BART trial presented at the American Society for Radiation Oncology...
PAM50 Subtyping Identifies Patients With Prostate Cancer Most Likely to Benefit From Apalutamide
Assessment with a genomic test could help predict which patients with recurrent prostate cancer are most likely to benefit from the addition of hormonal therapy to radiation following prostatectomy, according to findings from the phase II BALANCE trial (NRG GU006) presented in a press briefing...
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...
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...
