AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients

The company states: “Datroway, or Dato-DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval by the US Food and Drug Administration was based on results from the TROPION-Breast01 Phase III trial. In TROPION-Breast01, Datroway significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy in patients with HR-positive, HER2-negative metastatic breast cancer as assessed by blinded independent central review. Median progression-free survival was 6.9 months in patients treated with Datroway versus 4.9 months with chemotherapy. The safety profile of Datroway was consistent with the known profile of this medicine with no new safety concerns identified. In the Datroway arm, the interstitial lung disease rate was 4.2% and the majority of events were low grade.”