The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection.
Regulatory
Affordable treatment for recurrent melanoma
From 1 March 2023, Australians with recurrent melanoma will have a new treatment option subsidised by the Pharmaceutical Benefits Scheme (PBS).
FDA news: Breast cancer, melanoma agents win fast track, orphan drug status
The FDA announced several regulatory actions the past few weeks.
Iovance to Address FDA Requests for BLA of Lifileucel in Advanced Melanoma
After receiving recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel (LN-44) in the treatment of advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application (BLA) submission during the first quarter of 2023.