Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy. The approval was granted based on results of Daiichi’s DESTINY-BREAST04 phase III trials. Enhertu® combines a biosimilar to Gententech’s Herceptin® (trastuzumab) with chemotherapy drug deruxteca.
In August 2022, the FDA provided accelerated approval of Enhertu® for metastatic non-small cell lung cancer where tumours have activating HER2 mutations.