The Zhitong Finance App learned that on February 19, Daiichi Sankyo/AstraZeneca (AZN.US) jointly announced that its dato-DXD biological product license application (BLA) was accepted by the FDA for adult patients with locally advanced or metastatic non-squamous NSCLC who have previously received systemic treatment. The PDUFA date is December 20, 2024.
According to data, Dato-DXD (Datopotamab deruxtecan) is a TROP2 ADC jointly developed by Daiichi Sanhe and AstraZeneca. The payload is a topoisomerase 1 inhibitor, linked by a tumor-specific lyzable linker, and the DAR value is ~4. With this approval, it will be the world's first TROP ADC to treat lung cancer. This listing is based on the results of the critical Phase III Tropion-LUNG01 trial.
At the 2023 ESMO conference, the positive results of the first phase III clinical Tropion-Lung01 study obtained by Dato-DXD were announced. The data showed that dato-DXD monotherapy could significantly increase patients' PFS, and the non-scaled NSCLC subgroup benefited more significantly.