AstraZeneca and Daiichi Adjust Strategy for Dato-Dxd Approval in Lung Cancer

Following the mixed results of clinical studies, AstraZeneca and Daiichi Sankyo have revised their strategy for seeking FDA approval of their lung cancer drug, datopotamab deruxtecan (Dato-Dxd). Initially aimed at a broader approval, the companies are now targeting a narrower patient group with metastatic non-small cell lung cancer (NSCLC) characterized by EGFR gene mutations, specifically those who have received prior systemic therapies including EGFR-targeting drugs[1][2]. This strategic shift was prompted by the TROPION-Lung01 trial, which did not achieve a statistically significant improvement in overall survival relative to chemotherapy, despite showing longer progression-free survival for Dato-Dxd[2]. To support their case, AstraZeneca and Daiichi are relying on a pooled analysis of studies, while continuing to test Dato-Dxd in multiple Phase 3 trials for both lung and breast cancer[1].