Regulatory approval
Published by the Food and Drug Administration. Accelerated
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| FDA (1) | ERBB2 activating variants | Non-Small Cell Lung Cancer | Trastuzumab deruxtecan |