FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of NSCLC October 6, 2026
NDA Submission Initiated for Zipalertinib + Chemo in 1L EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program October 6, 2026
Ifinatamab Deruxtecan BLA for Certain Patients with Previously Treated ES-SCLC Voluntarily Withdrawn October 1, 2026
New Analyses Reinforcing Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC Announced September 22, 2026
Ph 2 ALISCA®-Lung2 Trial of Alisertib + Paclitaxel Initiated for Patients with Advanced SCLC September 22, 2026
Complete Full Cohort Ph 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent NSCLC Announced September 22, 2026
GX-BP1 Suppresses Tumor Regrowth despite Osimertinib and Dato-DXd Combination and Achieves 6/6 Complete Responses in Triple Combination September 22, 2026
Updated Data from Ph 1/2 SOLARA Trial Demonstrating Encouraging Anti-Tumor Activity of BH-30643 in EGFR C797S-Positive NSCLC Presented September 22, 2026
SYS6010 granted breakthrough therapy designation by NMPA in China for patients with actionable genomic alteration-negative non-squamous NSCLC September 22, 2026
FDA approves supplemental NDA for IBTROZI® (taletrectinib) for the treatment of locally advanced or metastatic ROS1+ NSCLC September 22, 2026
KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for SubQ Administration for All KEYTRUDA Indications Approved in Japan September 22, 2026
Gotistobart Nearly Doubled Median OS versus SOC Chemo in Previously Treated Squamous NSCLC Patients September 16, 2026
Zipalertinib + chemo Demonstrates 6-Month Median PFS Benefit in REZILIENT3 Ph 3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC September 16, 2026
Complete Full Cohort Ph 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent NSCLC Announced September 16, 2026
Positive results announced from registrational Ph 1/2 ARROS-1 trial of Jideytro (zidesamtinib) in patients with advanced or metastatic TKI-naive ROS1-positive NSCLC September 16, 2026
