Izalontamab Brengitecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated NSCLC August 19, 2025
U.S. FDA grants accelerated approval to HERNEXEOS® for previously treated patients with HER2-mutant advanced NSCLC August 12, 2025
First patient dosed in pivotal Ph 3 AK112-305/HARMONi-8A trial of ivonescimab + docetaxel for PD-1/L1i & chemo-refractory NSCLC August 5, 2025
Targeted Enrollment Completed for Lung Cancer Ph 2 Harmonic™ Trial in Japan for LP-300 August 5, 2025
Preliminary Safety & Efficacy Data Announced from Trial of IMM2510/AXN-2510 in Combination with Chemo in 1L NSCLC in China August 5, 2025
NMPA accepts NDA for sevabertinib (BAY 2927088) for previously treated NSCLC patients with HER2/ERBB2 mutations July 29, 2025
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
