Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

Lunit and Labcorp Partner to Transform Tumor Microenvironment Analysis with AI-Powered Digital Pathology

Lunit; Labcorp; artificial intelligence; digital pathology; tumor microenvironment; spatial profiling; biomarker discovery; precision oncology; non-small cell lung cancer (NSCLC); MET exon 14 skipping mutation

Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer

Nuvalent; neladalkib; ALK inhibitor; ALKOVE-1 trial; Phase 1/2 data; non-small cell lung cancer (NSCLC); lorlatinib; Lorbrena; FDA; clinical trial; objective response rate; CNS activity

Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025, Highlighting Integration of Clinical Innovation, Multi-Omics, and AI for Solid Tumor Therapies

Candel Therapeutics; SITC 2025; immunotherapy; CAN-2409; multi-omics; artificial intelligence; solid tumors; enLIGHTEN Discovery Platform; prostate cancer; non-small cell lung cancer; precision medicine

ESMO 2025 KEYNOTE-671 Update: Perioperative Pembrolizumab Reinforces NSCLC Standard

KEYNOTE-671; pembrolizumab; KEYTRUDA; perioperative immunotherapy; NSCLC; overall survival; event-free survival; ESMO Congress; standard of care

ChemDiv’s Discovery Platform Enables Differentiated, Reversible Pan-EGFR Kinase Inhibitors for GFR-Mutant Lung Cancer

ChemDiv; Discovery Platform; EGFR; Reversible Pan-EGFR Inhibitors; NSCLC; Kinase Inhibitors; Wild-Type EGFR Sparing; Kinome Selectivity; AI-Guided Drug Design; CMC Readiness; Lead Optimization

Recent Trends in Biomarker Testing for NSCLC: Maximizing Real-World Survival

NSCLC; biomarker testing; overall survival; PD-L1; EGFR; ALK; next-generation sequencing; liquid biopsy; precision medicine; real-world data

AstraZeneca Escalates EGFR Lung Cancer Rivalry with J&J: Tagrisso Combo Posts Survival Win

AstraZeneca; Tagrisso; EGFR-mutated NSCLC; Johnson & Johnson; Rybrevant; Lazcluze; Flaura2 trial; overall survival; lung cancer; chemotherapy combination

Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial

Akeso; Summit Therapeutics; ivonescimab; PD-1xVEGF; bispecific antibody; non-small cell lung cancer; progression-free survival; Phase 3 trial; overall survival; FDA approval

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu