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# Regulatory Review Determined for Daiichi’s Enhertu
- URL: https://www.fdaweb.com/regulatory-review-determined-for-daiichis-enhertu/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150495

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), indicated for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The review period is 1,395 days, which includes 186 days that occurred during the testing phase and 1,209 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-01/pdf/2021-23725.pdf?ref=fdaweb.com).