AstraZeneca: FDA Grants ENHERTU Priority Review For Metastatic HER2-Positive Solid Tumors

(RTTNews) - 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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