AstraZeneca: FDA application for lung cancer drug approval
(CercleFinance.com) - AstraZeneca and Daiichi Sankyo announce that they have submitted a new Biologics License Application (BLA) in the US for accelerated approval of datopotamab deruxtecan (Dato-DXd) in adult patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior therapy.
This submission is based on data from ph. I, II and III trials.
The decision to submit this new BLA and withdraw the previous one for advanced non-squamous NSCLC was taken following feedback from the FDA.
Datopotamab deruxtecan is being jointly developed by AstraZeneca and Daiichi Sankyo, who are also conducting further Phase III trials to confirm these results.
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This submission is based on data from ph. I, II and III trials.
The decision to submit this new BLA and withdraw the previous one for advanced non-squamous NSCLC was taken following feedback from the FDA.
Datopotamab deruxtecan is being jointly developed by AstraZeneca and Daiichi Sankyo, who are also conducting further Phase III trials to confirm these results.
Copyright (c) 2024 CercleFinance.com. All rights reserved.