Moderna’s experimental personalised mRNA skin cancer vaccine – in combination with Merck’s drug Keytruda – has received breakthrough therapy designation from the US Food & Drug Administration (FDA) as an additional treatment for high risk patients.
The breakthrough tag is granted based on data from a mid-stage study showing the therapy reduced risk of skin cancer’s recurrence or death by 44%, compared with Keytruda alone, and expedites the development and review of a drug intended to treat a serious condition, reports Reuters.
The companies said they would be starting a late-stage study in adjuvant treatment of melanoma this year.
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