Gilteritinib

In a phase III trial, 371 patients were randomly assigned in a 2:1 ratio to receive either gilteritinib or preselected salvage chemotherapy (MEC, FLAG-Ida, azacitidine, or low-dose cytarabine).[16,17]

In a phase III trial, 371 patients were randomly assigned in a 2:1 ratio to receive either gilteritinib or preselected salvage chemotherapy (MEC, FLAG-Ida, azacitidine, or low-dose cytarabine).[16,17]

With a median follow-up of 37.1 months, the median overall survival (OS) was 9.3 months for patients who received gilteritinib versus 5.6 months for patients who received chemotherapy (hazard ratio [HR] for death, 0.665; 95% confidence interval [CI], 0.52–0.85). The estimated OS rate at 2 years was 20.6% (95% CI, 15.8%–26.0%) for patients who received gilteritinib and 14.2% (95% CI, 8.3%–21.6%) for patients who received chemotherapy.[16] Among those treated with gilteritinib, the median duration of complete response or complete response with partial hematologic recovery was 10 months (interquartile range [IQR], 2.08–not evaluable), and 23 months (IQR, 4.9–not evaluable) for just those achieving a complete response.[17]

In a phase III trial, 371 patients were randomly assigned in a 2:1 ratio to receive either gilteritinib or preselected salvage chemotherapy (MEC, FLAG-Ida, azacitidine, or low-dose cytarabine).[16,17]

The rates of complete response and complete response with partial hematologic recovery were higher in patients who received gilteritinib than in patients who received chemotherapy (34% vs. 15.3%; HR, 18.6; 95% CI, 9.8–27.4).

In a phase III trial, 371 patients were randomly assigned in a 2:1 ratio to receive either gilteritinib or preselected salvage chemotherapy (MEC, FLAG-Ida, azacitidine, or low-dose cytarabine).[16,17]

Adverse events of grade 3 or higher were less common in patients who received gilteritinib when adjusted for exposure time.[16][Level of evidence A1] The most common adverse event of interest was increased liver transaminases for patients who received gilteritinib therapy. If liver transaminase levels (considered related to treatment) increase to more than 5 times the upper limit of normal, gilteritinib therapy is paused. When the enzymes return to less than 2.5 times the upper limit of normal, therapy can resume at a reduced dose of 80 mg once daily.[17][Level of evidence A1]