Moderna Inc said on Wednesday its experimental personalised mRNA skin cancer vaccine in combination with Merck & Co Inc's drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients.
drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients.The breakthrough tag is granted by the U.S. Food and Drug Administration 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.Our Standards:
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