Daiichi Sankyo and AstraZeneca Secure Approval for Datopotamab Deruxtecan in Advanced EGFR-Mutated NSCLC
Tuesday, December 10, 2024
Daiichi Sankyo has secured approval for Datopotamab Deruxtecan (Dato-DXd) for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC).
This indication applies to patients who have experienced disease progression after prior treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
Datopotamab Deruxtecan is a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed with AstraZeneca.
The therapy has shown promising potential in improving patient outcomes. It incorporates DXd ADC technology, combining a humanised anti-TROP2 IgG1 monoclonal antibody developed in collaboration with Sapporo Medical University with topoisomerase I inhibitor payloads (exatecan derivatives) via tetrapeptide-based cleavable linkers.
An extensive global clinical development programme supports Datopotamab Deruxtecan, involving over 20 trials to evaluate its efficacy and safety across multiple cancers, including NSCLC, triple-negative breast cancer, and HR-positive, HER2-low or HER2-negative breast cancer.
This includes seven phase 3 lung cancer trials and five phase 3 breast cancer trials assessing Datopotamab Deruxtecan as a monotherapy and in combination with other cancer therapies.
Lung cancer, with nearly 2.5 million cases diagnosed globally in 2022, is classified into small cell and non-small cell types, with the latter accounting for approximately 80 percent of cases. Among NSCLC patients, EGFR mutations are found in 10-15 percent of cases in the U.S. and Europe and 30-40 percent of cases in Asia, predominantly in tumours with nonsquamous histology.
Datopotamab Deruxtecan receives U.S. breakthrough therapy designation for advanced EGFR-Mutated non-small Cell lung cancer in previously treated patients.
Source: Daiichi Sankyo
