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Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

February 28, 2023

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.

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