We announced today that mRNA-4157/V940, an investigational personalized #mRNA #cancer vaccine, in combination with KEYTRUDA, @Merck's anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by the U.S. FDA for the adjuvant treatment of patients with high-risk #melanoma following complete resection. The FDA granted Breakthrough Therapy Designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. The FDA’s Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint. Read more: