Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; with an expected Prescription Drug User Fee Act target action date of 23 February 2022.
Immunocore today announces that regulators in the United States and European Union have each accepted applications for the approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma.
