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News
Japan's health ministry just approved two antibody-drug conjugates for metastatic breast cancer. T-DXd plus pertuzumab is now cleared for HER2-positive disease, while Dato-DXd gets the nod for triple-negative breast cancer in patients who can't receive immunotherapy. Both approvals are backed by phase 3 trial data showing meaningful survival improvements over standard chemotherapy.
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved two antibody-drug conjugates (ADCs) for first-line metastatic breast cancer treatment. Trastuzumab deruxtecan (T-DXd; Enhertu) combined with pertuzumab is now approved for HER2-positive unresectable or recurrent breast cancer, while datopotamab deruxtecan (Dato-DXd; Datroway) is approved for triple-negative breast cancer (TNBC) in patients who aren't candidates for PD-1/PD-L1 inhibitor therapy.
These approvals mirror decisions already made by the FDA — T-DXd plus pertuzumab in December 2025 and Dato-DXd in May 2026 — and are supported by robust phase 3 trial data. T-DXd represents the first new treatment regimen for metastatic HER2-positive breast cancer in over a decade, while Dato-DXd is the only TROP2-directed therapy to show an overall survival benefit in first-line TNBC.
By the Numbers:
Why it matters: These approvals expand access to two of oncology's most promising ADCs for patients with aggressive forms of breast cancer, offering significantly longer survival and response durations compared to existing chemotherapy regimens.
