Elexacaftor/tezacaftor/ivacaftor is indicated in a combination regimen with ivacaftor for CF patients >12-years old who are homozygous for the F508del mutation or heterozygous for F508del and a minimal-function CFTR mutation (EMA) or at least one F508del mutation (FDA). The gene discussed is CFTR; the disease is cystic fibrosis.