FDA Pipeline: Designation in Uveal Melanoma, Application for MDS Side-Effect Management
Over the past week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for metastatic uveal melanoma and received a biologics application for an agent to control anemia.
Fast Track Designation for Tebentafusp in Metastatic Uveal Melanoma
The FDA granted Fast Track designation for tebentafusp in the treatment of patients who are HLA-A*0201–positive with previously untreated, metastatic uveal melanoma.
Tebentafusp is being studied in the IMCgp100-202 trial, 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 overall survival.
Tebentafusp has previously been granted Orphan Drug designation for melanoma by the FDA. It has also received Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme.
Submission of Luspatercept Biologics License Application
A biologics license application was submitted this week for luspatercept—an erythroid maturation agent—for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes–associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for the treatment of adult patients with beta-thalassemia–associated anemia who require RBC transfusions.
The submission is based on the safety and efficacy results of the phase III MEDALIST and BELIEVE studies, both of which were recently reported at the American Society of Hematology Annual Meeting.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
