FDA Orphan Drug Designation granted to MVdeltaC for the treatment of pleural mesothelioma 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Deruxtecan BLA for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC Voluntarily Withdrawn June 3, 2025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
MAA submitted to the EMA for Zepzelca® (lurbinectedin) + Tecentriq for the maintenance treatment of adult patients with ES-SCLC May 27, 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
U.S. FDA granted Fast Track Designation for ZL-1310 for Treatment of Extensive-Stage SCLC 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
IND Clearance obtained for Ph 1b/2 Trial of LP-184 + ICIs in NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression May 13, 2025
First patient dosed in the randomized Ph 1/2 study of roginolisib in combination with dostarlimab with or without docetaxel, in advanced NSCLC patients May 13, 2025
Elironrasib monotherapy demonstrated acceptable tolerability and encouraging initial antitumor activity in previously treated G12C NSCLC patients May 13, 2025
Sandoz enters global collaboration license agreement with Henlius to commercialize ipilimumab in multiple indications May 6, 2025
Higher Exposure of AFM24 Associated with Significantly Higher Response Rates and PFS in Refractory NSCLC Patients May 6, 2025
Ivonescimab + Chemo combo yields Statistically Significant PFS vs. Tislelizumab + Chemo in Chinese Patients with 1L Squamous NSCLC in HARMONi-6 Study April 30, 2025
Interim OS Analysis Shows a Clinically Meaningful, Positive Trend Favoring Ivonescimab vs Keytruda in PD-L1+ve Advanced NSCLC from HARMONi-2 Study April 30, 2025
Ivonescimab Receives NMPA Approval for 1L Treatment of PD-L1-Positive NSCLC, Based on Ph 3 Trial Demonstrating Superior Efficacy Over Keytruda April 30, 2025
Ph 3 AdvanTIG-302 trial unlikely to meet primary endpoint; Ociperlimab (BGB-A1217) Program to be discontinued April 16, 2025
Ph 3 DeLLphi-304 trial of IMDELLTRA (tarlatamab-dlle) in SCLC patients met primary endpoint at a planned interim analysis April 16, 2025
