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# Daiichi Sankyo Drug OK’d for Lung Cancer
- URL: https://www.fdaweb.com/daiichi-sankyo-drug-okd-for-lung-cancer/
- Published: 2025-06-23T12:00:00.000Z
- Updated: 2026-09-14T15:14:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159399

FDA has approved a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) 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.

The drug was granted accelerated approval based on data from a pooled subgroup of 114 patients from two clinical trials — TROPION-Lung05 and TROPION-Lung01, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery). In the trials, the major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR). ORR was 45% and median DOR was 6.5 months, it says.

The drug’s prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.