AstraZeneca-Daiichi Sankyo Datopotamab deruxtecan gets USFDA Breakthrough Therapy Designation for previously treated advanced EGFR-mutated non-small cell lung cancer
Cambridge: AstraZeneca has announced that Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
The US Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
The FDA granted this BTD based on data from the TROPION-Lung05 Phase II trial with supporting data from the TROPION-Lung01 Phase III trial. Results from a pooled analysis of patients with previously treated EGFRm NSCLC in these studies were presented this month at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. This is the first BTD for datopotamab deruxtecan.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “This Breakthrough Therapy Designation reinforces datopotamab deruxtecan as a promising potential therapy for patients with EGFR-mutated lung cancer who continue to face significant unmet needs following disease progression on or after initial treatments. We are proud to have long supported patients with EGFR-mutated lung cancer and look forward to the possibility of bringing another innovative treatment option to this community.”
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said, “The Breakthrough Therapy Designation granted by the FDA underscores the significant unmet need for new treatments for patients with previously treated EGFR-mutated non-small cell lung cancer who have experienced disease progression. Datopotamab deruxtecan has the potential to play an important role in improving outcomes and we look forward to working closely with the FDA to bring this medicine to patients as quickly as possible.”
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.
AstraZeneca and Daiichi Sankyo recently announced the submission of a new Biologics License Application for accelerated approval in the US for datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFRm NSCLC who have received prior systemic therapies, including an EGFR-directed therapy.
