FDA Approval Alert: The Need-to-Know | Dato-DXd in Pretreated EGFR-Mutated Metastatic NSCLC

In June 2025, the FDA granted accelerated approval to datopotamab deruxtecan (dato-DXd) as a treatment for patients with pretreated EGFR-mutant metastatic non–small cell lung cancer.

Explicating Early-Line Treatment Considerations for EGFR-Mutant NSCLC
Explicating Early-Line Treatment Considerations for EGFR-Mutant NSCLC
Article
Aug 4, 2025 6:00 PM
Following the approval of dato-DXd in untreated EGFR-mutant NSCLC, Jacob Sands, MD, discussed next steps for improving outcomes for this disease.
Jacob Sands, MD, discussed considerations for EGFR-mutant non–small cell lung cancer following the approval of dato-DXd in this disease.
Integrating Dato-DXd Into Early-Line EGFR-Mutant NSCLC Management
Podcast
Aug 4, 2025 12:00 PM
Jacob Sands, MD, discussed considerations for EGFR-mutant non–small cell lung cancer following the approval of dato-DXd in this disease.
A combined cohort composed of patients from the TROPION-Lung01 and TROPION-Lung-05 trials showed a survival advantage with dato-DXd vs docetaxel.
Dato-DXd Shows Favorable Benefit in EGFR-Mutant NSCLC
Video
Aug 1, 2025 10:00 PM
A combined cohort composed of patients from the TROPION-Lung01 and TROPION-Lung-05 trials showed a survival advantage with dato-DXd vs docetaxel.
Osimertinib/chemotherapy and amivantamab/lazertinib have exhibited an efficacy advantage vs osimertinib in patients with EGFR-mutant NSCLC.
Outlining Historical Standard Therapies for EGFR-Mutant NSCLC
Video
Aug 1, 2025 12:00 PM
Osimertinib/chemotherapy and amivantamab/lazertinib have exhibited an efficacy advantage vs osimertinib in patients with EGFR-mutant NSCLC.
The decision is supported by results from the phase 2 TROPION-Lung05 and phase 3 TROPION-Lung01 trials.
Dato-DXd Earns FDA Accelerated Approval in Pretreated EGFR-Mutated mNSCLC
Article
Jun 23, 2025 5:54 PM
The decision is supported by results from the phase 2 TROPION-Lung05 and phase 3 TROPION-Lung01 trials.