Gilentinib generic drug price in Laos

Gilteritinib, as a FLT3 inhibitor, has demonstrated significant clinical activity in patients with FLT3-mutated (FLT3mut) relapsed/refractory (R/R) acute myeloid leukemia (AML). To further investigate the effects of FLT3 mutation clearance and the achievement of composite complete response (CRc) and complete response/complete response with partial hematologic recovery (CR/CRh) on overall survival (OS), we conducted an evaluation based on a phase 1/2 trial.

In this study, we used next-generation sequencing technology to define FLT3-ITD clearance in patients with nonmorphologic leukemia (i.e., CRc) with FLT3-ITD variant allele frequency of ≤10^-4. A total of 108 patients with FLT3-ITD-positive (FLT3-ITD) relapsed and refractory AML were included, of whom 95 patients were treated with gilitinib at ≥ 80 mg daily.

Treatment results showed that 10 of the 95 patients achieved FLT3-ITD clearance, and 8 of the 10 patients also achieved CRc and were confirmed to be negative for measurable residual disease. Further analysis found that patients who achieved CRc but did not achieve FLT3-ITD clearance (n=41; median OS was 43.3 weeks) compared with patients who achieved both CRc and FLT3-ITD clearance (n=10; median OS was 131.4 weeks) showed a longer OS trend (HR=0.416; p=0.066)。

In addition, among patients treated with ≥80 mg daily and achieving CR/CRh (n=24), seven patients achieved FLT3-ITD clearance. In particular, for patients treated with 120 mg daily of geritinib, the median OS was significantly longer in patients who achieved CR/CRh, compared with those who did not achieve CR/CRh (n=71; Median OS was 41.7 weeks; The 52-week survival probability is 20.2%), compared to 66.7% for 52-week survival.

These data strongly demonstrate the ability of gilitinib to induce deep molecular responses in patients with relapsed and refractory AML with FLT3-ITD. More importantly, these molecular responses are closely related to prolonged survival in patients who achieve CRc or CR/CRh, providing new therapeutic hope for patients with FLT3 mutation-positive relapsed/refractory AML.