The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab (Opdivo) and relatlimab (Opdualog) for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.
Regulatory
Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. Additionally, CHMP recommended expanding the indication for pembrolizumab in advanced unresectable or metastatic and stage III melanoma as adjuvant therapy following complete resection for adolescent patients aged 12 years and older.
EMA adopts positive opinion for Keytruda in melanoma following complete resection
A committee of the European Medicines Agency recommended the approval for expanded use of Keytruda (pembrolizumab) as a standalone therapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma who have undergone complete resection.
Positive FDA Feedback Supports BLA Submission for Lifileucel in Melanoma
The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application (BLA) seeking the approval of lifileucel (LN-144) in the treatment of patients with metastatic melanoma.