2025 FDA Lung Cancer Approvals: Precision Medicine and Immunotherapy Advances
“The year 2025 has been a pivotal period for thoracic oncology, characterized by a series of landmark approvals from the FDA that further segment the treatment landscape of non–small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The regulatory decisions this year have largely emphasized the role of precision medicine, with the introduction of novel antibody-drug conjugates (ADCs) and next-generation tyrosine kinase inhibitors (TKIs) targeting specific molecular alterations. Additionally, new strategies in the maintenance setting for SCLC have provided much-needed options for this aggressive disease.”
NCC identifies CREB, a key regulatory factor in lung cancer drug resistance
“The National Cancer Center (NCC) announced Monday that a research team led by Dr. Yoon Kyung-sil from the Cancer Metastasis Research Department has found that the protein CREB plays a key role in lung cancer drug resistance. CREB is a key regulator of resistance to platinum-based anticancer drugs used in chemotherapy for various cancers, including lung cancer, and elucidates their mechanism of action.”
FDA Clears Five-Minute Lung Cancer Shot, Redefining EGFR Treatment
“HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has won U.S. Food and Drug Administration approval for RYBREVANT FASPRO, the first and only subcutaneous therapy for patients with EGFR-mutated non-small cell lung cancer, marking a significant shift in how a leading lung cancer treatment is delivered. The approval allows RYBREVANT FASPRO to be used across all existing indications for RYBREVANT, replacing intravenous infusions that can take hours with a five-minute injection. The move sharply reduces treatment time and eases pressure on infusion centers while improving the patient experience.”
Advice for Patients Newly Diagnosed With Lung Cancer
“Establishing a support system is crucial for patients who are newly diagnosed with lung cancer, as an expert explained in a recent interview with CURE. CURE spoke with Patricia I. Moreno, who holds a Ph.D. and is a licensed clinical psychologist and lead of evidence-based survivorship and supportive care at Sylvester Comprehensive Cancer Center, part of the University of Miami Health System.”
Blood test finds seven times more cancers than standard screenings
“Screening, diagnosing and curing cancer at its earliest, most treatable stages has become a welcome and regular occurrence for radiation oncologist Nima Nabavizadeh, M.D.. This has been made possible by a simple blood test that can not only detect more than 50 types of cancer, but also pinpoint where it’s coming from with striking accuracy.”
Redefining How to Communicate Treatment Options May Facilitate Equitable Clinical Trial Enrollment
“Clinical trials are an integral part of high-quality cancer care, providing patients with access to novel therapies and advancing treatment paradigms. To ensure the generalizability of the results and equitable access to cutting-edge treatments, it is crucial that the enrollment to clinical trials reflects the diversity of the broader patient population. Despite the passing of the National Institutes of Health Revitalization Act of 1993, which mandated the inclusion of women and minorities in federally funded research, trial enrollment among underserved groups remains disproportionately low. With underrepresentation, findings from clinical trials may not be generalizable to all populations, thus limiting our understanding of how different groups may respond to treatments. Moreover, it may further contribute to inequitable care across different populations.”
Inflammation fuels one of the most aggressive forms of lung cancer
“A research team led by Professor Dr. Silvia von Karstedt (Translational Genomics, CECAD Cluster of Excellence on Aging Research, and Center for Molecular Medicine Cologne—CMMC) has discovered a novel mechanism used by this type of cancer that helps explain its aggressive nature. The study titled “Lack of Caspase 8 Directs Neuronal Progenitor-like reprogramming and Small Cell Lung Cancer Progression” is published in Nature Communications.”
A retrospective analysis of liver dysfunction and its risk factors in lung cancer patients receiving PD-1/PD-L1 inhibitor therapy
“These findings highlight that approximately one-fifth of patients experienced hepatic toxicity during immune checkpoint blockade, with advanced age, alcohol intake, reduced functional status, PD-1 agent use, and multidrug protocols significantly elevating risk. Enhanced vigilance and personalized treatment strategies are essential to minimize toxicity and ensure safer immunotherapy delivery in vulnerable populations.”
Video:
Dr Sands on Challenges in the Diagnosis and Management of LEMS in SCLC
