Moderna’s combination skin cancer therapy receives FDA’s breakthrough tag
Moderna Inc (MRNA.O) said on Wednesday its experimental personalised mRNA skin cancer vaccine in combination with Merck & Co Inc’s (MRK.N) drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients.
Shares of Moderna rise 2.5% to $164 after the market.
The breakthrough tag is granted by the U.S. Food and Drug Administration (FDA) based on data from a mid-stage study of the drug that showed the therapy reduced risk of skin cancer’s recurrence or death by 44% compared with Keytruda alone.
The FDA’s breakthrough therapy designation is granted to expedite the development and review of drugs that are intended to treat a serious condition.
The companies said they plans to initiate a late-stage study in adjuvant treatment of melanoma in 2023.
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