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# RemeGen Breakthrough Status for Disitamab Vedotin
- URL: https://www.fdaweb.com/remegen-breakthrough-status-for-disitamab-vedotin/
- Published: 2020-09-25T12:00:00.000Z
- Updated: 2026-09-14T16:30:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147739

FDA has granted RemeGen a Breakthrough Therapy designation for disitamab vedotin (RC48), an anti-HER2 antibody drug conjugate for second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer who have also previously received platinum-containing chemotherapy treatment. Earlier this year, the agency approved the company’s IND for a Phase 2 clinical study in the U.S., and it granted the therapy a Fast Track designation. RemeGen says RC48 was developed as a novel antibody with a higher affinity to HER2 compared to standard of care, and “superior anti-tumor activity compared to other treatments in animal models.”