FDA Breakthrough Therapy Designation for Elironrasib for KRAS G12C-mutated locally advanced or metastatic NSCLC July 29, 2025
ALKAZAR Ph 3 Trial of Neladalkib for Patients with TKI-naïve ALK-positive NSCLC initiated July 23, 2025
ZEGFROVY (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for NSCLC with EGFR Ex 20 Insertion Mutations July 8, 2025
Revolution Medicines and Summit Therapeutics to Evaluate Combinations of Three RAS(ON) Inhibitors with Ivonescimab in RAS Mutant Tumors July 1, 2025
Positive pivotal data announced for zidesamtinib in TKI pre-treated patients with ROS1-positive NSCLC from ARROS-1 Ph 1/2 trial July 1, 2025
Positive Interim Firmonertinib Monotherapy Data Announced From Global Ph 1b Study in EGFR PACC Mutant NSCLC; Plans to Advance into a Global Pivotal Study June 24, 2025
Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of NSCLC June 17, 2025
Dose escalation completed in IAM1363-01 Ph 1/1b trial of IAM1363 in patients with HER2-altered cancers & brain mets / HER2 TKD mutation / HER2-amplified NSCLC June 10, 2025
Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant NSCLC June 3, 2025
Patritumab Deruxtecan BLA for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC Voluntarily Withdrawn June 3, 2025
Ivonescimab + Chemo Demonstrates Statistically Significant PFS Improvement and numerical OS improvement in topline data in EGFRm NSCLC after EGFR TKI June 3, 2025
EU approved Neoadjuvant Opdivo + Chemo Followed by Adjuvant Opdivo for Resectable, High-Risk NSCLC with PD-L1 Expression ≥1% based on CheckMate-77T trial results May 21, 2025
FAILED TRIAL: GALAXIES Lung-201 of Belrestotug + Dostarlimab in 1L PD-L1 High NSCLC Patients did not meet PFS endpoint May 21, 2025
FDA Approves EMRELIS (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced NSCLC With High c-Met Protein Overexpression May 21, 2025
FDA Clears IND for Ph 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need May 21, 2025
CPO301 granted the fast track designation by U.S. FDA for the treatment of adult patients with NSCLC May 21, 2025
