TP53 and myelodysplastic syndrome: Clinical and preclinical data showed that the combination of APR-246 and azacytidine (AZA) showed synergistic activity in patients with myelodysplastic syndromes (MDS), AML and solid tumors carrying TP53 mutations with an acceptable safety and tolerability profile.415–420 Food and Drug Administration and European Medicines Agency have granted APR-246 orphan drug status and FTD for the treatment of MDS carrying the TP53 mutation.