Moderna and Merck announced on Feb. 22, 2023 that their investigational personalized messenger RNA (mRNA) cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by FDA for the adjuvant treatment of patients with high-risk melanoma following complete resection.
FDA’s decision was based on positive data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial. Breakthrough Therapy Designations are granted to accelerate 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.
