FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
“On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.”
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
“On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib.”
Age-Based Screening for Lung Cancer Surveillance in the US
“Meaning These findings suggest that current screening guidelines miss most patients with lung cancer, and age-based screening could improve detection and cost-effectiveness while reducing disparities.”
Data from Genprex’s Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer
“AUSTIN, Texas, Nov. 24, 2025 /PRNewswire/ — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso® (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.”
Breath-based lung cancer detection using an ML-driven low-cost sensor array
“Our system outperforms existing e-nose detection methods by more than 5% and is capable of classifying in approximately 5 minutes. These findings highlight the potential of this breath analyzer system as a rapid and cost-effective tool for preliminary lung cancer screening.”
The Incidence, Severity and Risk Factors of Renal Injury in Lung Cancer Patients Receiving Osimertinib Therapy: A Real-World Study
“Conclusions: This study demonstrates that renal injury is not rare in lung cancer patients treated with osimertinib, particularly in patients aged ≥ 60 years or with pre-existing renal injury. Although most cases are reversible, regular monitoring of renal function is strongly recommended for these patients.”
Visugromab Plus Nivolumab Shows Durable Response in Refractory Tumors
“Key Takeaways: Visugromab combined with nivolumab showed a median duration of response exceeding two years in refractory NSCLC, UC, and HCC patients. GDF-15 is a therapeutic target and immune escape mechanism, contributing to checkpoint inhibitor resistance and cancer cachexia.”
Blood-Based Screening Test May Increase Preclinical Lung Cancer Detection
“Results from the National Lung Screening Trial (NLST; NCT00047385) revealed that the Mercy Halo blood-based lung screening test displayed a significant improvement in the detection of early-stage preclinical lung cancer, especially among patients at an elevated risk who were not currently engaged in low-dose CT screening programs, according to a news release from the developer, Mercy BioAnalytics.”
Adherence to Posttreatment Surveillance Guidelines in Non-Small Cell Lung Cancer: Retrospective Cohort Study
“Conclusions: In this unique application of a competing risks framework, the rate of guideline-concordant surveillance in this national cohort was lower than that reported in many previous studies. This finding highlights a potentially substantial gap in surveillance among eligible, asymptomatic lung cancer survivors. More strategies are needed to measure the true rate of guideline-concordant surveillance, along with education and advocacy to ensure guideline-concordant care.”
What the Data Show: Lung Cancer Down, Youth Vaping Down, Inequities Up
“While there has been some advancement in tobacco prevention and control efforts, tobacco-related disparities persist. These disparities do not reflect individual choices. They reflect long-standing inequities in access to quality health care, early detection, and treatment. Communities of color, particularly Black residents, have faced decades of underinvestment, limited access to preventive services, higher exposure to predatory tobacco marketing, and environmental stressors that increase their risk of morbidity and mortality. These inequities require a comprehensive approach that includes equitable access to lung cancer screening and treatment, access to evidence-based tobacco cessation resources, and tobacco prevention education for those at higher risk.”
Researchers engineer a novel technique for guiding endoscopes to deep lung tumors
“Researchers at The University of Osaka have engineered a novel technique, Balloon-Assisted Bronchoscope Delivery (BDBD), to guide endoscopes to small, early-stage lung cancers hidden deep within the periphery of the lungs. By using a small balloon to gently widen the airways, this innovative method overcomes the physical limitations of conventional bronchoscopy, promising to revolutionize both the accuracy of early diagnosis and the potential for minimally invasive treatment.”
