FDA Grants Breakthrough Status for Moderna and Merck’s Vaccine Combo Therapy for Skin Cancer

February 24, 2023

Moderna and Merck have secured a win with the US Food and Drug Administration (FDA) granting breakthrough therapy designation to the companies’ experimental therapy for skin cancer. The treatment combines a new mRNA vaccine with Merck’s existing drug Keytruda to help the immune system fight melanoma.

According to Emily Kimber, “A breakthrough therapy designation is given by the US Food and Drug Administration (FDA) to accelerate the development and regulatory review of potential new medicines for serious conditions that address a significant unmet medical need. The FDA’s decision for mRNA-4157/V940 plus Keytruda was supported by positive results from a phase 2b trial in which the combination reduced risk of recurrence or death by 44% compared with Merck’s anti-PD-1 therapy alone.”

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(Source: PM Live, February 24th, 2023)

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