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.
Regulatory
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.
FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma
Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma