LONDON (dpa-AFX) - British drug maker AstraZeneca Plc (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK) announced Monday that their Datroway (datopotamab deruxtecan) has been approved in the United States for patients with previously treated metastatic HR-positive, HER2-negative breast cancer.
Datroway, a specifically engineered TROP2-directed antibody drug conjugate or ADC, was discovered by Daiichi Sankyo, and is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The approval by the U.S. Food and Drug Administration is the first in the country for Datroway based on TROPION-Breast01 Phase III trial results, which showed 37% reduction in the risk of disease progression or death vs. chemotherapy.
Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor or HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
TROPION-Breast01 is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy and safety of intravenous Datroway (6 mg/kg) once per 21-day cycle versus investigator's choice of single-agent chemotherapy in adult patients. TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America.
In the trial, 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 or BICR. According to the companies, median progression-free survival was 6.9 months in patients treated with Datroway versus 4.9 months with chemotherapy.
Datroway's safety profile was consistent with the known profile of this medicine with no new safety concerns identified. In the Datroway arm, the interstitial lung disease or ILD rate was 4.2% and the majority of events were low grade.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said, 'With this first approval of Datroway in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers. We are proud to bring Datroway to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.'
Additional regulatory submissions for Datroway in breast cancer are under review in the European Union, China and other regions.
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