FDA Grants Accelerated Approval for Trastuzumab Deruxtecan, Recognizing HER2+ as a Tumor-Agnostic Biomarker
The FDA has granted accelerated approval to trastuzumab deruxtecan (Enhertu) for treating adult patients with unresectable or metastatic HER2-positive solid tumors, highlighting HER2-positive as a tumor-agnostic biomarker. The approval is based on successful results from the DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 clinical trials.