Trastuzumab deruxtecan is an engineered HER2-targeted antibody-drug conjugate jointly developed and marketed by AstraZeneca and Daiichi Sankyo.
The FDA has accepted an additional biologic license application (sBLA) of trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2) low breast cancer and who have prior therapy in the metastatic setting.
Trastuzumab deruxtecan is a specifically engineered HER2-targeted antibody-drug conjugate (ADC) jointly developed and marketed by AstraZeneca and Daiichi Sankyo. The sBLA is being reviewed as part of the Real-Time Oncology Review (RTOR) program and Project Orbis, two FDA initiatives designed to provide patients with safe and effective cancer treatment as early as possible.
“The data from DESTINY-Breast04 represent the first time that a HER2-targeted therapy has demonstrated a survival benefit in patients with HER2-low metastatic breast cancer. For more than 2 decades, only patients with HER2-positive breast cancer have been able to benefit from HER2-targeted therapies. If approved, [trastuzumab deruxtecan] will redefine how we classify and treat metastatic breast cancer, giving patients whose tumors have lower levels of HER2 expression the opportunity to benefit from HER2-targeted therapy,” said Susan Galbraith, executive vice president of Oncology Research and Development at AstraZeneca, in a statement.
RTOR allows the FDA to review elements of an application prior to submitting the completed application, while Project Orbis provides a framework for concurrent submission and review of oncology medications with participating international partners. In addition, the FDA has received a priority review of the application.
The FDA assigns priority review to drug applications that, if approved, would provide significant improvements over currently available options by demonstrating improvements in safety or efficacy, preventing a serious condition, or improving patient compliance.
The date of the Prescription Drug Reimbursement Act is in the fourth quarter of 2022.
The sBLA is based on the date of the DENSITY-Breast04 Phase 3 study presented at the presidential plenary session of the 2022 American Society of Clinical Oncology Annual Meeting. The findings were published in the New England Journal of Medicine.
In the study, trastuzumab deruxtecan demonstrated superior and clinically meaningful efficacy in both progression-free survival and overall survival in those previously treated and had HER2-low metastatic breast cancer with hormone receptor (HR) positive or HR negative disease compared to standard chemotherapy.
The safety profile of trastuzumab deruxtecan was consistent with previous clinical studies with no new safety concerns identified. Interstitial lung disease or pneumonitis rates were consistent with those observed in late-line HER2-positive breast cancer trials of the drug.
“The results seen in the DESTINY-Breast04 study represent significant progress and reinforce the potential for [trastuzumab deruxtecan] to become a new standard of care for patients with previously treated HER2-low metastatic breast cancer,” said Ken Takeshita, global head of Research and Development at Daiichi Sankyo, in a statement.
In the European Union and Japan, regulatory evaluations are also underway for trastuzumab deruxtecan in the HER2-low population.
Enhertu granted Priority Review in the US for patients with HER2-low metastatic breast cancer. news item. AstraZeneca. July 25, 2022. Accessed July 25, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-granted-priority-review-for-her2-low-mbc.html