Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan. The drug is approved for treating adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer who have undergone prior chemotherapy.
First TROP2-Directed Therapy in Japan
Datroway represents a significant advancement as the first-ever TROP2-directed medicine in Japan for HR positive, HER2 negative breast cancer. It is Daiichi Sankyo’s second DXd antibody drug conjugate (ADC) developed using its proprietary DXd ADC Technology.
Clinical Trial Results Leading to Approval
The December 2024 marketing approval was based on results from the Phase III TROPION-Breast01 study. In this trial, Datroway demonstrated superior efficacy by significantly reducing the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (P<0.0001). This result, assessed by blinded independent central review (BICR), was observed in patients with HR positive, HER2 negative metastatic breast cancer. Patients treated with Datroway achieved a median progression-free survival (PFS) of 6.9 months, compared to 4.9 months in those receiving chemotherapy.
Collaboration with AstraZeneca
Datroway is co-developed by UK pharmaceutical major AstraZeneca (NASDAQ: AZN) under a pact signed in July 2020. Daiichi Sankyo holds responsibility for the drug’s global supply and exclusive rights in Japan, marking a strategic milestone in the company’s oncology portfolio expansion.-Fineline Info & Tech
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