ENHERTU Granted Priority Review in the US for Patients with HER2 Low Metastatic Breast Cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU is the first HER2 directed therapy to demonstrate a survival benefit in this population

Application being evaluated under FDA Real-Time Oncology Review and Project Orbis

Daiichi Sankyo and AstraZeneca have received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU^® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior therapy in the metastatic setting. The application has been granted Priority Review.

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

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is during the fourth quarter of the 2022 calendar year. The Priority Review follows receipt of Breakthrough Therapy Designation, granted by the FDA in April 2022 for ENHERTU in metastatic HER2 low breast cancer.

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 results seen in the DESTINY-Breast04 trial represent a significant advance and reinforce the potential for ENHERTU to become a new standard of care for patients with previously treated HER2 low metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The prioritization of this application by the FDA and inclusion in both the Real-Time Oncology Review and Project Orbis initiatives support the importance of these data, and we look forward to working with the FDA to potentially bring ENHERTU to patients with HER2 low metastatic breast cancer as quickly as possible.”

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“The data from DESTINY-Breast04 represent the first time a HER2 targeted therapy has shown a survival benefit in patients with HER2 low metastatic breast cancer,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “For more than two decades, only patients with HER2 positive breast cancer have been able to benefit from HER2 targeted therapies. If approved, ENHERTU will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumors have lower levels of HER2 expression the opportunity to benefit from a HER2 directed therapy.”

The sBLA is based on data from the DESTINY-Breast04 phase 3 trial recently presented at the presidential plenary session of the American Society of Clinical Oncology (#ASCO22) Annual Meeting and simultaneously published in The New England Journal of Medicine. In DESTINY-Breast04, ENHERTU demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR negative disease versus standard of care physician’s choice of chemotherapy. The safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) or pneumonitis rates were consistent with those observed in other late-line HER2 positive breast cancer trials of ENHERTU, as determined by an independent adjudication committee.

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