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
Regulatory
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…
FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma
The FDA has granted an orphan drug designation to alrizomadlin (APG-115) as a potential therapeutic option for patients with stage IIB-IV melanoma, according to an announcement from Ascentage Pharma, the drug developer.1