FDA Accepts BLA for Ivonescimab + Chemo in EGFRm NSCLC Post-TKI Therapy; PDUFA Nov 2026 February 1, 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
Tagrisso + chemo demonstrated statistically significant and clinically meaningful improvement in OS in EGFR-mutated advanced lung cancer July 23, 2025
ZEGFROVY (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for NSCLC with EGFR Ex 20 Insertion Mutations July 8, 2025
NMPA approves ORPATHYS + TAGRISSO combo in China for the Treatment of Lung Cancer Patients with MET Amplification After Progression on 1L EGFR Inhibitor July 1, 2025
BMJ Publishes results from OptiTROP-Lung03 trial of sacituzumab tirumotecan (sac-TMT) vs docetaxel in patients with previously treated EGFR-mutant NSCLC June 10, 2025
European Commission approves SC RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated NSCLC April 8, 2025
In LAURA Ph 3 trial, Tagrisso continues to demonstrate improved OS trend in unresectable, Stage III setting April 2, 2025
European Commission approves RYBREVANT (amivantamab) + LAZCLUZE (lazertinib) for the 1L treatment of patients with EGFR-mutated advanced NSCLC January 7, 2025
Tagrisso approved in the EU for patients with unresectable EGFR-mutated lung cancer December 25, 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated NSCLC November 19, 2024
CHMP recommends RYBREVANT® (amivantamab) + LAZCLUZE® (lazertinib) for 1L treatment of patients with EGFR-mutated advanced NSCLC November 19, 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer based on Ph 3 LAURA trial results November 19, 2024
BDTX-1535 program to be advanced into pivotal development based on robust Ph 2 clinical data from EGFRm NSCLC patients October 15, 2024
Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer October 2, 2024
Patritumab Deruxtecan Demonstrated Statistically Significant PFS Improvement vs Chemo in Locally Advanced or Metastatic EGFRm NSCLC in HERTHENA-Lung02 Ph 3 Trial September 24, 2024
RYBREVANT® (amivantamab-vmjw) + SOC approved in the US to cut risk of disease progression by more than half in 2L EGFR-mutated advanced NSCLC September 24, 2024
RYBREVANT (amivantamab-vmjw) + LAZCLUZE (lazertinib) show strong favorable OS trend versus osimertinib in EGFR-mutated advanced lung cancer September 10, 2024
European Commission approves RYBREVANT (amivantamab) + chemo for adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy September 3, 2024
RYBREVANT (amivantamab-vmjw) + LAZCLUZE (lazertinib) approved in the U.S. for patients with EGFR-mutated advanced lung cancer August 27, 2024
TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC August 27, 2024
CHMP recommends RYBREVANT + chemo for the treatment of adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy July 30, 2024
Tagrisso + chemo approved in the EU as new 1L treatment for patients with EGFR-mutated advanced lung cancer July 9, 2024
