31 August 2023 - Designations for Daiichi Sankyo and AstraZeneca's Enhertu include patients with HER2 expressing metastatic solid tumours and HER2 positive metastatic colorectal cancer.

Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted two additional breakthrough therapy designations in the US for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive metastatic colorectal cancer who have received two or more prior regimens.