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DATROWAY® Approved in Japan for HR Positive, HER2 Negative Breast Cancer

NextEdge Admin

28 Dec 2024

2 min 40 sec

Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+, or IHC 2+/ISH-) unresectable or recurrent breast cancer following prior chemotherapy. This marks the first TROP-2-directed therapy approved in Japan for this indication and the second DXd antibody-drug conjugate (ADC) developed with Daiichi Sankyo’s proprietary technology.

Breast cancer remains the most common cancer among Japanese women, with approximately 92,000 cases diagnosed and 17,600 deaths in 2022. About 70% of breast cancer cases in Japan are classified as HR positive, HER2 negative.

The approval was based on results from the TROPION-Breast01 phase 3 trial, where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator-chosen chemotherapy (hazard ratio [HR] = 0.63; p<0.0001). Median progression-free survival (PFS) was 6.9 months for DATROWAY versus 4.9 months for chemotherapy.

In the trial, 93.6% of patients treated with DATROWAY experienced adverse reactions, including nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%), and dry eye (21.7%). Interstitial lung disease (ILD) occurred in 6.5% of Japanese patients and is flagged as a significant risk with a warning label.

To mitigate ILD risks, therapy requires close collaboration with respiratory experts, patient monitoring for symptoms (e.g., dyspnea, cough, fever), and regular imaging and oxygen saturation checks. Treatment should be discontinued immediately if ILD is suspected, with corticosteroids administered as needed.

“This approval provides patients with metastatic HR positive, HER2 negative breast cancer a new alternative to conventional chemotherapy,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo, emphasizing the company’s commitment to innovative cancer care.