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ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors

Source: Daiichi Sankyo

Tokyo and Basking Ridge, NJ – (January 29, 2024) – Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.

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

The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is May 30, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in August 2023 for ENHERTU in metastatic HER2 positive solid tumors.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

The sBLA is based on data from the ongoing DESTINY-PanTumor02 phase 2 trial where ENHERTU demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2 expressing advanced solid tumors. Data from other supporting trials in patients with HER2 positive IHC 3+ tumors in the ENHERTU clinical development program, including DESTINY-Lung01 and DESTINY-CRC02, also were included in the submission.

“The clinical benefit seen across HER2 expressing metastatic solid tumors in the DESTINY-PanTumor02 trial and ongoing data from the ENHERTU clinical development program continues to demonstrate the potential of this medicine beyond its approved indications,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, ENHERTU could become the first HER2 directed therapy and antibody drug conjugate with a tumor agnostic indication, providing patients with a potential new treatment option.”

“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,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. We will continue working closely with the FDA to bring this potential first tumor agnostic HER2 targeted medicine to patients as quickly as possible.”

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