The Scottish Medicines Consortium (SMC) accepted Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for restricted use within NHSScotland as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer when patients have received one or more prior anti HER2 based regimens. The SMC relied on a phase III study in which trastuzumab deruxtecan was associated with significantly improved progression-free survival compared with an antibody-drug conjugate medication.
On 27 March 2023, Daiichi Sankyo announced that Enhertu® was 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.