FDA Fast Track Designation: Tebentafusp in Metastatic Uveal Melanoma
Posted: Monday, April 15, 2019
The U.S. Food and Drug Administration recently granted Fast Track designation for tebentafusp in the treatment of patients who are HLA-A*0201–positive with previously untreated, metastatic uveal melanoma. Tebentafusp has previously been granted Orphan Drug designation for melanoma by the FDA.
Tebentafusp is being studied in the IMCgp100-202 trial (ClinicalTrials.gov identifier NCT03070392), a 2:1 randomized study of tebentafusp compared with investigator’s choice (dacarbazine, ipilimumab, or pembrolizumab) in HLA-A*0201–positive adult patients with previously untreated metastatic uveal melanoma. The primary endpoint is a comparison of overall survival.