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HomeNews UpdateFDA grants breakthrough tag for Moderna’s melanoma drug

FDA grants breakthrough tag for Moderna’s melanoma drug

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.

 

Reuters article – Moderna's combination skin cancer therapy receives FDA's breakthrough tag (Open access)

 

See more from MedicalBrief archives:

 

Moderna-Merck personalised vaccine lowers skin cancer risk in trial

 

FDA approves Merck’s Ketruda — first new treatment for bladder cancer in 20 years

 

GEMS backs down and agrees to cover patient's Keytruda treatment

 

Keytruda boosts event-free survival by up to 39% in early triple-negative breast cancer

 

 

 

 

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