Datroway

Datroway is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. The application for Datroway was submitted on 12 February 2024, and a CHMP positive opinion was issued on 30 January 2025. The Marketing Authorisation Application status is approvable.

In efficacy studies, Datroway demonstrated a median Overall Survival (OS) of 23.9 months, 14.4 months, and 11.2 months in different cohorts. In xenograft models, Datroway showed tumor growth inhibition ranging from 82.8% to 96.1%. The recommended clinical dose for patients weighing less than 90 kg is 6 mg/kg, administered once every 3 weeks, with a maximum dose of 540 mg for patients weighing 90 kg or more.

Regarding safety, the highest human Cmax of DXd was 3.13 ng/mL. In animal studies, the terminal elimination half-life of datopotamab deruxtecan in cynomolgus monkeys was 1.5-2 days. The maximum non-lethal dose of datopotamab deruxtecan was reported as 200 mg/kg and 80 mg/kg. Abnormal skin color was observed at a dose of 30 mg/kg, and loss of fur and body weight decreases were noted at 200 mg/kg.