US FDA Approves AstraZeneca's Datroway for Advanced Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan) for adult patients with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC).
AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
The approval follows Priority Review and Breakthrough Therapy Designation by the FDA. It is based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial, supported by data from the TROPION-Lung01 Phase III trial. Datroway is the first TROP2-directed therapy approved in the US for the treatment of lung cancer.
In the TROPION-Lung05 and TROPION-Lung01 trials, Datroway demonstrated a confirmed objective response rate (ORR) of 45% in previously treated patients with advanced EGFR-mutated NSCLC. The median duration of response was 6.5 months. The safety profile observed was consistent with the known profile of the medicine.
AstraZeneca and Daiichi Sankyo are jointly developing Datroway and are investigating it in other advanced or metastatic NSCLC settings. AstraZeneca will make a $45 million milestone payment to Daiichi Sankyo following this approval.