> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Daiichi Sankyo Enhertu Approved for Lung Cancer
- URL: https://www.fdaweb.com/daiichi-sankyo-enhertu-approved-for-lung-cancer/
- Published: 2022-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:55:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152502

FDA has granted Daiichi Sankyo accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating human epidermal growth factor receptor 2 HER2 mutations (as detected by an FDA-approved test). The agency also approved Life Technologies’ Oncomine Dx Target Test (tissue) and Guardant Health’s Guardant360 CDx (plasma) as companion diagnostics for Enhertu. “If no mutation is detected in a plasma specimen, the tumor tissue should be tested,” the agency [says](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung?ref=fdaweb.com).

Approval was based on data from the DESTINY-Lung02 clinical trial involving 52 patients. The major efficacy outcome measures were confirmed objective response rate (ORR) and duration of response (DOR), according to FDA. The confirmed ORR was 58% and the median DOR was 8.7 months, it says.