The sBLA is based on data from the DESTINY-Breast04 Phase III trial that were presented at the presidential plenary session of the 2022 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. The prioritisation 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.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “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.
If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumours have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy.” For more than two decades, only patients with HER2-positive breast cancer have been able to benefit from HER2-targeted therapies. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “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. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. RTOR allows the FDA to review components of an application before submission of the complete application. The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the fourth quarter of 2022.
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The Food and Drug Administration (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 application has been granted Priority Review.Įnhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
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Partnerships, alliances and recognitionĪstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry 1+ or IHC 2+/in-situ hybridisation -negative) breast cancer who have received a prior therapy in the metastatic setting.
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