Daiichi Sankyo
CHMP Recommends European Approval for AstraZeneca, Daiichi Sankyo's Datroway in Breast Cancer
The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Ultralow Breast Cancer Patients
The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.
AstraZeneca, Daiichi Sankyo Begin Phase III Trial of Datroway in High-Risk Early-Stage NSCLC
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu in HER2-Ultralow Breast Cancer
The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.
FDA Approves AstraZeneca, Daiichi Sankyo's Datroway for HR-Positive, HER2-Negative Breast Cancer
This marks the first US approval for AstraZeneca and Daiichi Sankyo's Trop-2-directed antibody drug conjugate.