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
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
Jacobio Pharma Enters Global Exclusive License Agreement with AstraZeneca for Pan-KRAS Inhibitor JAB-23E73 December 30, 2025
Trethera Receives $2.7M NIH Grant for TRE-515 to Overcome KRAS Inhibitor Resistance in Lung Cancer December 22, 2025
US FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and LAZCLUZE® (lazertinib) combo for 1L EGFRm NSCLC December 22, 2025
Ph 2 Portion of ALKOVE-1 Trial for Patients with ALK+ve NSCLC and other Solid Tumors initiated February 26, 2024
Erasca Announces Two Clinical Trial Collaboration & Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 & SEACRAFT-2 Trials February 26, 2024
Jazz Pharmaceuticals Enters Definitive Agreement with Redx Pharma to Acquire Global Rights to KRAS Inhibitor Program February 26, 2024
Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant NSCLC January 23, 2024
European Commission Approves KRAZATI (adagrasib) for Patients with Advanced NSCLC with a KRASG12C Mutation January 17, 2024
FDA Issued New Postmarketing Requirement on Supplemental NDA seeking full approval of LUMAKRAS® (sotorasib) January 10, 2024
FDA Approves Augtyro™ (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive NSCLC December 4, 2023
EXKIVITY® (mobocertinib) to be voluntary withdrawn from the U.S. for adult patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy October 11, 2023
New Lumakras® (Sotorasib) Plus Chemotherapy Data In First-Line KRAS G12C NSCLC announced September 19, 2023
Phase III ALINA study of Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) September 6, 2023
Application For Lumakras® (Sotorasib) For The Treatment Of KRAS G12C-Positive NSCLC To be Discussed At FDA Advisory Committee Meeting September 6, 2023
Retevmo® (selpercatinib) Demonstrated Superior PFS vs a PD-1 Inhibitor + Chemo for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive NSCLC August 9, 2023
EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation July 27, 2023
C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919 June 6, 2023
Tagrisso achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years in ADAURA Ph 3 trial June 6, 2023
