Posted by Michael Wonder on 27 Feb 2026
Enhertu supplemental new drug application submitted in Japan as adjuvant therapy for patients with HER2 positive early breast cancer
27 February 2026 - Submission based on DESTINY-Breast05 phase 3 trial results, which showed Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine.
Daiichi Sankyo has submitted a supplemental new drug application to Japan’s MHLW for Enhertu (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 positive (immunohistochemistry [IHC] 3+ or in situ hybridisation (ISH)+) breast cancer with residual invasive disease after neo-adjuvant therapy.
