The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage 2B or 2C melanoma.
Publications
FDA news: License applications accepted for melanoma, endometrial cancer therapies
The FDA announced several regulatory actions the past few weeks.
FDA Grants Priority Review to Lifileucel in Advanced Melanoma
The FDA has granted priority review to the biologics license application (BLA) for the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy.
EMA Awards PRIME Scheme Designation to mRNA-4157/V940 Plus Pembrolizumab in High-risk Melanoma
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.