AstraZeneca and Daiichi Sankyo Refocus Approval Strategy for Lung and Breast Cancer Drug Dato-DXd

AstraZeneca and Daiichi Sankyo have recalibrated their approval approach for the cancer drug datopotamab deruxtecan (Dato-DXd) following mixed clinical trial results. The companies decided to retract their initial broad application for Dato-DXd as a treatment for non-squamous non-small cell lung cancer (NSCLC) due to the lack of statistically significant overall survival benefit compared to chemotherapy. Instead, they are now pursuing a more focused approval for patients with EGFR-mutated NSCLC who have previously received systemic therapies, including EGFR-targeted treatments[1][2]. This strategic pivot seeks accelerated approval based on findings from a pooled analysis of various studies, thereby narrowing the drug's market but mitigating the risk of regulatory rejection. Additionally, AstraZeneca continues to explore the potential of Dato-DXd in combination therapies and in different cancer indications, including breast cancer[2].