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NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults May 12, 2026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
LP-300 Demonstrates 8.3-Month Median PFS in Patients with EGFR L858R Lung Cancer After Targeted Therapy Failure — With No Added Toxicity April 28, 2026
Boehringer Ingelheim and Zai Lab announce collaboration on DLL3‑targeting T‑Cell Engager and ADC combination in SCLC and other Neuroendocrine Carcinomas April 21, 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
Ifinatamab Deruxtecan Granted Priority Review in the US for Adult Patients with Previously Treated ES-SCLC who Experienced Disease Progression on or After Platinum-Based Chemotherapy April 21, 2026
