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# FDA Accelerated Approval for Immunomedics’ Trodelvy
- URL: https://www.fdaweb.com/fda-accelerated-approval-for-immunomedics-trodelvy/
- Published: 2021-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:54:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149111

FDA granted accelerated approval 4/13 to Immunomedics’ Trodelvy (sacituzumab and govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Trodelvy’s safety and efficacy were evaluated in the TROPHY trial that enrolled 112 patients with the main efficacy endpoints of objective response rate and duration of response.

The indication was approved under accelerated approval based on tumor response rate and duration of response, FDA says. Continued approval for the indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

The agency review used the Real-Time Oncology Review pilot program, which streamlined data submission before the filing of the entire clinical application, and the Assessment Aid, a voluntary applicant submission to facilitate FDA assessment. The application was approved six weeks before the goal date.