The FDA granted Breakthrough Therapy Designation to T-DXd (trastuzumab deruxtecan) in combination with pertuzumab for first-line HER2-positive metastatic breast cancer.
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T-DXd Granted Breakthrough Therapy Designation by FDA in HER2+ Breast Cancer | CancerNetwork
Breakthrough Therapy FDA designation
12.8 Months Median DOR improvement
73.3% Vs 54.9% 24-month response rate
HR 0.84 Favorable OS trend
39.2 Months median DOR
0.84 OS hazard ratio
73.3% response rate at 24 months