On 15 May 2026, the FDA approved BMS/Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) for two separate breast cancer indications. The indications are:
- followed, by taxane, trastuzumab and pertuzumab (THP) for neoadjuvant treatment of adults with HER-2 positive Stage II or III breast cancer, as determined by an FDA-authorised test; and
- for the adjuvant treatment of adults with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane.
The first approval globally for Enhertu® for neoadjuvant treatment of HER2-positive early stage breast cancer came in March 2026 in China. Enhertu® has previously been approved for patients with HER2-positive metastatic breast cancer in more than 95 countries, including the US (2025).
Enhertu® is the subject of a March 2019 collaboration between AstraZeneca and Daiichi Sankyo, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Following the latest US breast cancer approvals, AstraZeneca is due to pay Daiichi Sankyo a milestone payment of US$155 million.
Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.