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# Corrected Regulatory Review Period for Enhertu
- URL: https://www.fdaweb.com/corrected-regulatory-review-period-for-enhertu/
- Published: 2022-01-11T12:00:00.000Z
- Updated: 2026-09-14T17:28:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150899

*Federal Register* notice: FDA is correcting a notice in the 11/1/2021 *Federal Register* that announced 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 corrected regulatory review period is 1,395 days, which includes 114 days that occurred during the testing phase and 1,281 days that occurred during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-00404.pdf?ref=fdaweb.com).