The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab (Opdivo) monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
Regulatory
Opdivo receives positive CHMP opinion for early stage melanoma
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.
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.