News

Patients treated with trastuzumab deruxtecan + pertuzumab had a statistically significant and clinically meaningful improvement in PFS compared with standard of care. Topline results were ...
Aditya Bardia, MD, MPH, FASCO, medical oncologist, UCLA Health, discusses findings from the TROPION-Breast01 study on datapotamab deruxtecan for patients with HR ...
In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA ...
Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...
On January 17, 2025, the Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk a Trop-2-directed antibody and topoisomerase inhibitor conjugate. This approval marks a significant ...
The FDA approved datopotamab deruxtecan (Datroway) for adults with unresectable or metastatic, hormone receptor (HR)-positive/HER2-negative breast cancer who have ...
AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult ...
Application based on TROPION-Lung05 trial and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials Approval would mark the first for AstraZeneca and Daiichi Sankyo’s datopotamab ...
Patients received Dato-DXd 6 mg/kg once every 3 weeks. The primary end point was objective response rate (ORR) by blinded independent central review. Secondary end points included duration of response ...
A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumour response in patients with ...
A regulatory decision is expected during the first quarter of 2025. The Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for ...