LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK)
announced Monday that the Food and Drug Administration has accepted and granted
Priority Review to the supplemental Biologics License Application or sBLA for
ENHERTU (fam-trastuzumab deruxtecan-nxki) in the US for patients with metastatic
HER2-positive solid tumors.

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate or
ADC being jointly developed and commercialized by AstraZeneca and Daiichi
Sankyo.

If approved, ENHERTU will potentially be the first HER2-directed treatment and
antibody drug conjugate to receive a tumor-agnostic indication.

The sBLA is for the treatment of adult patients with unresectable or metastatic
HER2-positive solid tumors who have received prior treatment or who have no
satisfactory alternative treatment options.

The companies noted that the sBLA is based on data from the ongoing
DESTINY-PanTumor02 Phase II trial. In this, ENHERTU demonstrated clinically
meaningful and durable responses leading to a clinically meaningful survival
benefit in previously treated patients across HER2-expressing metastatic solid
tumors, including biliary tract, bladder, cervical, endometrial, ovarian
cancers, and other tumors.

The submission also included data from other supporting trials in patients with
HER2-positive IHC3+ tumors in the ENHERTU clinical development program,
including DESTINY-Lung01 and DESTINY-CRC02.

The submission will be reviewed under FDA Real-Time Oncology Review and Project
Orbis.

The Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the second quarter of 2024.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said,
'Today's Priority Review for the first tumor-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 tumor types.'

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