On 27 March 2026, Daiichi Sankyo announced the conditional approval in China of Enhertu® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) for the neoadjuvant treatment of HER2 positive stage 2 or 3 breast cancer. According to Daiichi Sankyo, this is the first approval for Enhertu® globally for neoadjuvant treatment of HER2 positive early stage breast cancer.
The conditional approval is based on Phase III results from the DESTINY-Breast 11 trial, which demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response rate by administering Enhertu® followed by THP. Confirmation of long-term clinical benefit in patients with early or locally advanced breast cancer is required for full approval.
Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
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.