Therapeutic Response

EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Datopotamab deruxtecan in patients with Invasive Breast Carcinoma.

Statements

Source and description

Datroway (datopotamab deruxtecan-dlnk) [package insert]. FDA. 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.