Table 1 Current US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals for venetoclax
Indication | Regimen |
|---|---|
FDA | |
Treatment of patients with CLL with del(17p) who have been treated with at least one prior therapy [51] | Monotherapy |
Treatment of patients with CLL who have received at least one prior therapy [32] | 2Â years fixed duration, combined with rituximab |
Treatment of patients with previously untreated CLL [31] | 1Â year fixed duration, combined with obinutuzumab |
Treatment of patients with newly diagnosed AML who are ≥ 75 years old or ineligible for intensive induction due to comorbidities [151, 152] | Combined with azacytidine, decitabine or lose-dose cytarabine |
EMA | |
Treatment of patients with CLL with del(17p) or TP53 mutation who are unsuitable for or have failed a B cell receptor pathway inhibitor [51] | Monotherapy |
Treatment of patients without del(17p) or TP53 mutations who have failed both chemo-immunotherapy and a B cell receptor pathway inhibitor [55, 56] | Monotherapy |
Treatment of patients with CLL who have received at least one prior therapy [32] | 2Â years fixed duration, combined with rituximab |
Treatment of patients with previously untreated CLL [31] | 1Â year fixed duration, combined with obinutuzumab |
Treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy [151] | Combined with a hypomethylating agent |