Iovance Biotherapeutics has submitted a rolling biologics license application (BLA) to the FDA seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-44) for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.
Regulatory
FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
Positive data from the phase 2b KEYNOTE-942 trial (NCT03897881) have led to the FDA to grant a breakthrough therapy designation to mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection, according to Moderna, Inc.
FDA Grants Breakthrough Therapy Designation to mRNA-4157/V940 Plus Pembrolizumab in High-Risk Melanoma
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.
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).