Moderna mRNA Cancer Vaccine Gets FDA’s Breakthrough Therapy Designation
The U.S. Food and Drug Administration (FDA) has granted a “breakthrough therapy” designation to Moderna’s personalized mRNA skin cancer vaccine combined with a drug by Merck for treating patients with high-risk melanoma.
The “breakthrough therapy” designation has been granted to Moderna’s mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Merck’s anti-PD-1 therapy KEYTRUDA for “the adjuvant treatment of patients with high-risk melanoma following complete resection,” according to a news release on Feb. 22. The designation was based on positive data from the phase 2b trial.
Melanoma is characterized by uncontrolled growth of cells that produce pigment in the body, and is considered to be the most serious form of skin cancer….