The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.
Regulatory
FDA Grants Fast Track Status to UVI Plus Checkpoint Inhibition for Melanoma Subgroup
The FDA has granted a fast track designation to UV1, a universal cancer vaccine, in combination with either pembrolizumab (Keytruda) or…
FDA Grants Fast Track Status to Cancer Vaccine UV1 for Advanced Malignant Melanoma
The FDA has granted a fast track designation to the universal cancer vaccine UV1 for use in combination with checkpoint inhibitors in patients with unresectable or metastatic melanoma…
FDA and EMA Accept Tebentafusp Applications for Metastatic Uveal Melanoma
The FDA and the European Medicines Agency (EMA) have accepted applications seeking the approval of tebentafusp (IMCgp100) for use in the treatment of adult patients with HLA-A*02:01–positive metastatic uveal melanoma.1