On 1 October 2024, AstraZeneca and Daiichi Sankyo’s supplemental Biologics Licence Application for Enhertu® (fam-trastuzumab deruxtecan-nxki) was granted priority review by the US FDA. The treatment is proposed to be used in HER2-low or HER2 ultra-low unresectable or metastatic breast cancer patients who have previously received at least one metastatic-oriented endocrine therapy.
In January 2024, the FDA granted Priority Review for AstraZeneca/Daiichi Sankyo’s sBLA for Enhertu® to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.
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.