AstraZeneca's Lung Cancer Drug Gets US Priority Review
The US Food and Drug Administration (FDA) has granted Priority Review to AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan for patients with previously treated advanced EGFR-mutated non-small cell lung cancer.
AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). The drug is intended for adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including EGFR-directed treatment.
The FDA grants Priority Review to medicines that, if approved, could offer significant improvements over available options. The regulatory decision is anticipated during the third quarter of 2025. Datopotamab deruxtecan had previously received Breakthrough Therapy Designation from the FDA for this patient group.
The application and designation are based on data from the TROPION-Lung05 Phase II trial, supported by data from the TROPION-Lung01 Phase III and TROPION-PanTumor01 Phase I trials. Pooled analyses showed a confirmed objective response rate (ORR) of 42.7% and a median duration of response (DoR) of 7.0 months in previously treated patients. The safety profile was consistent with previous reports.
Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed by AstraZeneca and Daiichi Sankyo. If approved, it could offer a new treatment option for patients whose disease has become resistant to current therapies.