AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult 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.
👉 If approved, Enhertu will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumour-agnostic indication.
The sBLA is based on data from the ongoing DESTINY-PanTumor02 Phase II trial where Enhertu demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2-expressing metastatic solid tumours, including biliary tract, bladder, cervical, endometrial, ovarian cancers, and other tumours. Data from other supporting trials in patients with HER2-positive IHC3+ tumours in the Enhertu clinical development programme, including DESTINY-Lung01 and DESTINY-CRC02, were also included in the submission.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Today’s Priority Review for the first tumour-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers. Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumour types. We will continue working closely with the FDA to bring this potential first tumour-agnostic HER2-targeted medicine and biomarker to patients as quickly as possible.”
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “The clinical benefit seen across HER2-expressing metastatic solid tumours in the DESTINY-PanTumor02 trial and ongoing data from the Enhertu clinical development programme continues to demonstrate the potential of this medicine beyond its approved indications. If approved, Enhertu could become the first HER2-directed therapy and antibody drug conjugate with a tumour-agnostic indication, providing patients with a potential new treatment option.”
👉 Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours (astrazeneca.com)
