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…
Regulatory
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
FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma
Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.1
FDA Sets PDUFA Date for Pembrolizumab
Merck announced that its phase 3 KEYNOTE-716 (NCT03553836) trial investigating pembrolizumab (Keytruda) has met its primary endpoint…