FDA approves IND application for KST-0651 for Ph 1 trial in Advanced Solid Tumors including pancreatic cancer, CRC, NSCLC, and others March 10, 2026
SC RYBREVANT approved by European Commission for Q3W and Q4W dosing for patients with advanced EGFR-mutated NSCLC March 3, 2026
Synthekine and Merck to Evaluate STK-012, Keytruda, and Chemo in Ph 2 Trial in 1L PD-L1-Neg Nonsquamous NSCLC March 3, 2026
FDA approves monthly RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in 1L EGFR+ NSCLC February 25, 2026
Zenocutuzumab Treatment Beyond Progression Demonstrates Continued Benefit in Patients with NRG1+ NSCLC in New Results from the eNRGy Trial February 25, 2026
RMAT Designation Granted by FDA to KB707 for the Treatment of Advanced or Metastatic NSCLC February 17, 2026
Ph 3 LIBRETTO-432 trial of Retevmo (selpercatinib) met primary endpoint of EFS in patients with early-stage (II-IIIA) RET fusion-positive NSCLC February 17, 2026
FDA Accepts BLA for Ivonescimab + Chemo in EGFRm NSCLC Post-TKI Therapy; PDUFA Nov 2026 February 1, 2026
First Patient Dosed in Ph 1 Trial of RMC-5127 in patients with RAS G12V–mutated solid tumors February 1, 2026
Positive interim results announced from PK cohort of CLEER-001 trial of HT-001 in cancer patients receiving EGFR inhibitor therapy January 25, 2026
US FDA Clears Two IND Applications, Enabling Ph 1 Trial of D3S‑003 and Ph 2 Combo Study of Elisrasib (D3S‑001) with D3S‑002 January 25, 2026
Nuvation Bio and Eisai Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside the US, China and Japan January 18, 2026
TROPION-Lung17 TROP2 Biomarker Directed Ph 3 Trial of DATROWAY® Initiated in Patients with Previously Treated Advanced Nonsquamous NSCLC January 18, 2026
Ph 3 KANDLELIT-007 Trial of Calderasib + KEYTRUDA QLEX™ Merck Initiated in Certain Patients With Advanced NSCLC January 18, 2026
Positive Results Demonstrating ANKTIVA as a Lymphocyte Stimulating Agent in Combination with Checkpoint Inhibitors in NSCLC Announced January 18, 2026
Results from SACHI Ph 3 trial of savolitinib and osimertinib combination in EGFR mutation+ve NSCLC patients with MET amplification published in The Lancet January 18, 2026
BLA submitted to US FDA Seeking Approval for Ivonescimab + chemo Combo in 2L+ EGFRm NSCLC January 18, 2026
Ph 3 KANDLELIT-007 Trial of Calderasib (MK-1084) + KEYTRUDA QLEX Initiated in Certain Patients With Advanced NSCLC January 11, 2026
Breakthrough Therapy Designation in the US and China for sevabertinib in 1L HER2-mutant NSCLC January 11, 2026
Breakthrough Therapy Designation granted to zoldonrasib for previously treated KRAS G12D-mutated locally advanced or metastatic NSCLC January 11, 2026
Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) + Pembrolizumab for 1L PD-L1-Positive NSCLC January 4, 2026
