Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to datopotamab deruxtecan-dlnk for the treatment of adult patients with locally advanced or metastatic epidermal growth factor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is 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 the confirmatory trial. This approval is based on two clinical studies: TROPION-Lung05 and TROPION-Lung01, where efficacy was assessed in 114 patients with EGFR-mutated NSCLC. Fifty-three percent (53%) of patients had exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, 2.6% had exon 20 insertion mutations, and 14% had other EGFR mutations.
This is written in the approval document as:
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is 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 the confirmatory trial.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR somatic variants | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR p.T790M | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR Exon 20 (Insertion) | Invasive Breast Carcinoma | Datopotamab deruxtecan |