European Commission Approves Gilteritinib for FLT3-Mutated, Relapsed/Refractory AML

The European Commission approved the oral FLT3/AXL inhibitor gilteritinib as a single agent for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.

The agency’s decision was based on results from the randomized, open-label, phase III ADMIRAL trial, which compared the safety and efficacy of gilteritinib with salvage chemotherapy in 371 adults with relapsed or refractory FLT3-mutated AML.

After a median follow-up time of 17.8 months (range not reported), patients treated with gilteritinib had significantly longer overall survival (OS), compared with those who received salvage chemotherapy: 9.3 months versus 5.6 months (hazard ratio = 0.64 [95% CI 0.49-0.83]; p=0.0004). Rates of one-year OS were 37% for patients who received gilteritinib, compared with 17% for patients who received salvage chemotherapy (p value not reported).

The most common AEs across both treatment arms of the ADMIRAL trial were febrile neutropenia (43.7%), anemia (43.4%), and pyrexia (38.6%). Common grade ≥3 AEs related to gilteritinib treatment were anemia (19.5%), febrile neutropenia (15.4%), and thrombocytopenia (12.2%).

The U.S. Food and Drug Administration (FDA) approved gilteritinib for the same indication in November 2018.

Source: Astellas press release, October 25, 2019.