Datopotamab deruxtecan (Dato-DXd) is now an FDA-approved treatment for patients with hormone receptor-positive, HER2-negative breast cancer. The approval is supported by data from the phase 3 TROPION-Breast01 trial, which showed that Dato-DXd demonstrated better progression-free survival and overall response rates compared to chemotherapy.
In the trial, Dato-DXd was found to have a median progression-free survival of 6.9 months, while the chemotherapy arm had a median progression-free survival of 4.9 months. The confirmed overall response rate was 36%, with a median duration of response of 6.7 months.
The recommended dose of Dato-DXd is 6 mg/kg, administered via intravenous infusion, once every 3 weeks on a 21-day cycle. The FDA has approved Dato-DXd for patients who have received 1 to 2 prior lines of chemotherapy and have inoperable or metastatic HR+, HER2– breast cancer.
Safety data from the trial showed that the most common adverse events were laboratory abnormalities, such as stomatitis, nausea, fatigue, and alopecia. The recommended dose of Dato-DXd is expected to minimize these side effects.
Source: https://www.targetedonc.com/view/fda-approves-dato-dxd-in-hr-her2-breast-cancer