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.
Regulatory
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).
FDA news: Breast cancer, melanoma agents win fast track, orphan drug status
The FDA announced several regulatory actions the past few weeks.