Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer, who have received prior chemotherapy.
Phase III TROPION-Breast01 Study Results Support Approval
The approval in Japan is based on the positive results from the Phase III TROPION-Breast01 study. Datroway demonstrated a significant reduction in the risk of disease progression or death by 37% compared to the investigator’s choice of chemotherapy. The median progression-free survival (PFS) was 6.9 months for patients treated with Datroway, significantly longer than the 4.9 months observed in those treated with chemotherapy.
Safety Profile and Warning for ILD
Datroway exhibited an overall good tolerability profile, although the drug’s approval comes with a warning for interstitial lung disease (ILD), an adverse reaction that was observed in 6.5% of patients treated with the drug. This precaution is an important consideration for healthcare providers and patients.
Co-Development with AstraZeneca
Datroway (datopotamab deruxtecan) is a TROP-2 directed antibody drug conjugate (ADC) that was co-developed with UK-based AstraZeneca (NASDAQ: AZN) as part of an agreement established in July 2020. The collaboration highlights the synergy between the two companies in bringing innovative treatments to market for complex diseases like breast cancer.-Fineline Info & Tech
