Since its introduction in 2016, the drug mericitabine (originally developed as a treatment for brain cancers) has been approved for children ages 6 and older, although infants and children with cancer are eligible for a larger body of clinical trials. Now, the Food and Drug Administration has authorized the immunotherapy drug as an additional treatment option for children and teenagers with a BRAF V600E mutation in the melanoma genome.
The approval affects two types of melanoma, familial and metastatic. The U.S. Department of Health and Human Services, in collaboration with the National Cancer Institute, announced the findings of a grant program in March. The NIH’s Melanoma Institute for Research and Education became aware of this group of young patients who were eligible for a different immune therapy while pursuing an external validation of an immunotherapy drug.
Because the drug approved today is being developed in collaboration with the U.S. Department of Defense, it has been classified as medical countermeasure, which insures that it is specially manufactured and certified. Most of the revenue from drug sales will go to drug manufacturer Eli Lilly, Inc. The drug will be manufactured for 30 years under a prior manufacturing arrangement with the U.S. Department of Defense.