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# Regulatory Review Period for Immunomedics’ Trodelvy
- URL: https://www.fdaweb.com/regulatory-review-period-for-immunomedics-trodelvy/
- Published: 2021-11-24T12:00:00.000Z
- Updated: 2026-09-14T17:23:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150643

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), indicated for treating adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. The review period is 2,856 days, which includes 2,150 days that occurred during the testing phase and 706 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-24/pdf/2021-25612.pdf?ref=fdaweb.com).