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FDA Grants BLA for Dato-DXd to Treat Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer

The decision follows phase 3 trial results that demonstrated improved progression-free survival and confirmed the safety of Dato-DXd in patients with breast cancer. ....

Ken Takeshita , Susan Galbraith , Daiichi Sankyo , Sebastian Kaulitzki , Randomized Study , Versus Investigator , Participants With Inoperable , Two Prior Lines ,

Dato-Dxd Shows Survival Improvements in HR+/HER2– Breast Cancer

The dual primary end points of overall survival and progression-free survival were encouraging when patients with hormone receptor–positive (HR+), HER2-negative (HER2–) breast cancer were treated with datopotamab deruxtecan. ....

United States , Ken Takeshita , Daiichi Sankyo , Susan Galbraith , Oncology Research , Eastern Cooperative Oncology Group , Image Credit , North America , South America , Randomized Study , Versus Investigator , Participants With Inoperable , Two Prior Lines , Patients With Locally Recurrent Inoperable , Metastatic Triple Negative Breast Cancer , Who Are Not Candidates , Without Durvalumab Versus Investigator , Patients With Stage , Datopotamab Deruxtecan , Dato Dxd , Tropion Breast01 ,