Drug Approval | April 02, 2024
AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Application based on results from the TROPION-Breast01 Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
The validations confirm the completion of the applications and commence the scientific review process
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The overall transaction is expected to conclude over next 12-15 months subject to receipt of all relevant shareholder and regulatory approvals
Highlighting fully integrated organization, robust portfolio, and strategic priorities to drive long-term sustainable growth
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Comprehensive clinical development programs being initiated for each investigational candidate
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
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