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MONDAY, April 1, 2019 (HealthDay News) -- For patients with FMS-like tyrosine kinase 3 (FLT3) mutations who have relapsed or refractory acute myeloid leukemia (AML), gilteritinib results in longer overall survival and higher response rates than salvage chemotherapy (SC), according to a study presented at the annual meeting of the American Association for Cancer Research, held from March 29 to April 3 in Atlanta.

Alexander E. Perl, M.D., from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia, and colleagues randomly assigned adults with confirmed FLT3mut+ AML refractory to induction chemotherapy or in untreated first relapse to receive either continuous 28-day cycles of 120 mg/day gilteritinib (247 patients) or SC (124 patients).

The researchers found that patients assigned to gilteritinib had significantly longer overall survival (9.3 versus 5.6 months; hazard ratio for death, 0.637; P = 0.0007); survival rates at one year were 37.1 and 16.7 percent, respectively. The rates of complete remission/complete remission with partial hematologic recovery (CR/CRh) were 34.0 and 15.3 percent for gilteritinib and SC, respectively (P = 0.0001); CR rates were 21.1 and 10.5 percent (P = 0.0106). For the gilteritinib and SC arms, median event-free survival was 2.8 and 0.7 months, respectively (hazard ratio, 0.793; P = 0.0830). Per patient-year, serious treatment-emergent adverse events were less common with gilteritinib than SC.

"Across the board, this trial shows gilteritinib carries a clear survival benefit, meaning we now have a targeted, highly-effective, and well-tolerated treatment option for a group of truly high-risk patients," Perl said in a statement.

Gilteritinib is manufactured by Astellas Pharma, which funded the study.

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Updated on May 27, 2022

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