The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab (Keytruda) for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.
Regulatory
FDA Approval Sought for Adjuvant Nivolumab for Completely Resected Stage IIB/C Melanoma
The FDA has accepted the supplemental biologics license application for nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma.
FDA Accepts Supplemental BLA For Nivolumab For Melanoma
The FDA has accepted the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) as adjuvant monotherapy for patients with completely resected stage IIB or IIC melanoma, according to a Bristol Myers Squibb press release.1 The PDUFA date for this sBLA is October 13, 2023.
FDA Approval Sought for Lifileucel in Unresectable or Metastatic Melanoma
Iovance Biotherapeutics has submitted a rolling biologics license application (BLA) to the FDA seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-44) for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.