Breakthrough Therapy Designation

Raludotatug Deruxtecan

Raludotatug Deruxtecan: First-in-Class CDH6 ADC Earns FDA Breakthrough Status

The FDA has granted Breakthrough Therapy Designation to Raludotatug Deruxtecan (R-DXd), a CDH6-targeting ADC, for patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Early-phase trials show ORR 46% and DCR 98%.