AstraZeneca Plc and Daiichi Sankyo have announced that their drug, Datroway (datopotamab deruxtecan), has received approval in the United States for the treatment of patients with previously treated metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer. This approval marks the authorisation of Datroway by the U.S. Food and Drug Administration, based on the findings from the TROPION-Breast01 Phase III trial. The trial demonstrated a substantial 37% reduction in the risk of disease progression or death compared to chemotherapy.
Datroway is a TROP2-directed antibody drug conjugate (ADC), initially discovered by Daiichi Sankyo, and is being collaboratively developed and commercialized by AstraZeneca and Daiichi Sankyo. It is specifically designed for adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have previously undergone endocrine-based therapy and chemotherapy for such conditions.
The TROPION-Breast01 trial is a comprehensive global, randomized, multicentre, open-label Phase III study assessing the efficacy and safety of intravenous Datroway (6 mg/kg) administered every 21 days in comparison to the investigator's selected single-agent chemotherapy. This trial included 732 participants spanning Africa, Asia, Europe, North America, and South America. Results highlighted that Datroway significantly decreased the risk of disease progression or death by 37% relative to the chemotherapy option selected by investigators, with median progression-free survival reaching 6.9 months for those treated with Datroway compared to 4.9 months for chemotherapy recipients.
Safety evaluations revealed that Datroway's profile aligns with the known characteristics of this medication, with no new safety concerns emerging. In the Datroway treatment group, the occurrence rate of interstitial lung disease (ILD) was 4.2%, with the majority of cases being of low severity.
Dave Fredrickson, Executive Vice President of the Oncology Haematology Business Unit at AstraZeneca, commented, "This initial approval of Datroway in the U.S. reinforces our commitment to enhancing and possibly replacing conventional chemotherapy with antibody drug conjugates for treating various cancers. We are honored to introduce Datroway to individuals battling metastatic HR-positive, HER2-negative breast cancer. This new approval represents the eighth of the 20 new medicines we aim to deliver at AstraZeneca by 2030."
Additional regulatory reviews for Datroway in breast cancer are ongoing in the European Union, China, and various other regions.
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