Datroway (datopotamab deruxtecan or Dato-DXd), a novel TROP2-directed DXd antibody drug conjugate (ADC), has received accelerated approval in the US for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). This approval is specifically for patients who have already undergone prior EGFR-directed therapy and platinum-based chemotherapy. The decision, granted under Priority Review and Breakthrough Therapy Designation by the FDA, is based on compelling data from a subgroup analysis of the Phase II TROPION-Lung05 trial, further supported by results from the Phase III TROPION-Lung01 trial.

In these pivotal studies, Datroway demonstrated an objective response rate (ORR) of 45% (95% CI: 35-54) in the specified patient population, with 4.4% achieving complete responses and 40% experiencing partial responses. The median duration of response (DoR) was 6.5 months (95% CI: 4.2-8.4). This marks Datroway as the first and only TROP2-directed therapy approved in the US for lung cancer, addressing a significant unmet medical need for patients whose disease has progressed despite existing treatments. Experts like Dr. Jacob Sands of Dana-Farber Cancer Institute emphasize that this approval provides a much-needed new option for challenging cases of advanced EGFR-mutated lung cancer.

The safety profile of Datroway, evaluated across multiple trials including TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01, was consistent with its known profile, showing no new safety concerns. Developed by Daiichi Sankyo and jointly commercialized with AstraZeneca, Datroway is part of an extensive global clinical development program, with more than 20 trials underway, including eight Phase III trials in lung cancer. As an accelerated approval, continued US approval for this indication will be contingent upon further verification of clinical benefit in a confirmatory trial. This milestone triggers a $45 million milestone payment from AstraZeneca to Daiichi Sankyo.