Posted by Michael Wonder on 23 Jun 2025
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
23 June 2025 - Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer who have received prior EGFR directed therapy and platinum-based chemotherapy.
Efficacy was evaluated in a pooled sub-group of 114 patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer who had received prior treatment with an EGFR directed therapy and platinum-based chemotherapy and received datopotamab deruxtecan-dlnk at the recommended dose across two clinical trials: TROPION-Lung05 and TROPION-Lung01.
