The FDA, which has stopped short of requiring DPYD testing for patients before receiving fluoropyrimidines, emphasized the ...
The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.
Patients on the firm's SSTR-targeted radiopharmaceutical had improved progression-free survival compared to patients on an mTor inhibitor in a Phase III trial.