FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026 June 2, 2026
FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084) for Certain Patients with 1L Metastatic KRAS G12C-Mutant NSCLC June 2, 2026
Primary Endpoints Met in Final Analysis of Ph 3 Study for Perioperative Toripalimab plus Chemotherapy for Resectable Stage II-III NSCLC June 2, 2026
Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload May 26, 2026
First patient dosed in Spain in Ph 2 HLX43-NSCLC201 trial of HLX43 for the treatment of advanced NSCLC May 26, 2026
Successful Outcome of FDA Type C Meeting Request for HARMONIC Ph 2 Trial of LP-300 in Never-Smokers with NSCLC Announced May 26, 2026
FDA Grants Priority Review to Supplemental NDA for HYRNUO® (sevabertinib) Under Investigation in 1L HER2-Mutated NSCLC May 21, 2026
Part 1 Data From Ph 2 Trial of JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer Announced May 21, 2026
Supplemental NDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab in 1L PD-L1+ve NSCLC Accepted for Review by NMPA May 12, 2026
FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers May 12, 2026
NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults May 12, 2026
FDA Accepts Supplemental NDA for IBTROZI® (taletrectinib) with Updated DoR in Advanced ROS1+ve NSCLC May 12, 2026
US FDA Accepts NDA for Zipalertinib for the Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations May 6, 2026
Ph 3 STAR-121 study of domvanalimab, zimberelimab and chemo vs pembrolizumab + chemo in 1L NSCLC to be discontinued April 28, 2026
First US Site Activated for Ongoing International Ph 2 Expansion Trial of Novel Telomere Targeting Treatment Targeting Advanced NSCLC April 21, 2026
Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement and $350 Million Concurrent Private Placement April 21, 2026
MAIA Biotechnology Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Ph 3 Trial of Novel Telomere-Targeting Anticancer Therapy April 15, 2026
Updated Data on Cadonilimab Combination Therapy in PD-(L)1 Inhibitor–Resistant Advanced NSCLC Presented April 15, 2026
