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

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

Enhertu to demonstrate a significant survival benefit vs. chemotherapy

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone

ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial

Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients

Quizartinib Plus chemotherapy significantly improved overall survival compared to chemo

Doubling of median overall survival seen in QuANTUM-First results presented at EHA Presidential Symposium

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers

Enhertu Phase III results to redefine how metastatic breast cancer is classifed

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.