Datopotamab deruxtecan Biologics License Application accepted in US

eAwazMedicine

London – AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its …

First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan

eAwazMedicine

First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Plans for global regulatory submissions underway Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or …

Datopotamab deruxtecan combinations showed encouraging tumour responses

eAwazMedicine

London – Updated results from the TROPION-Lung02 Phase Ib trial showed that, with additional enrolment and follow-up from the initial presentation, datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGAs). Results …