Datopotamab deruxtecan (Dato-DXd) received FDA Priority Review for locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) after prior systemic therapies

The BLA is supported by data from the TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 trials, showing a 42.7% ORR and a mDoR of 7.0 months

Datopotamab deruxtecan was previously granted Breakthrough Therapy Designation (BTD) by the FDA for this patient population

If approved, Dato-DXd would become the first TROP2-directed antibody-drug conjugate (ADC) for lung cancer, addressing significant unmet medical needs

AstraZeneca and Daiichi Sankyo are conducting seven Phase III trials, including combinations with Tagrisso for advanced or metastatic EGFRm NSCLC