The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the product labeling for Xospata (gilteritinib; Astellas Pharma) to include final analysis data from the ADMIRAL trial demonstrating improvement in overall survival (OS).

In the ADMIRAL trial, 371 adult patients with FMS-like tyrosine kinase 3 (FLT3) mutations who are refractory to, or have relapsed after, first-line acute myeloid leukemia (AML) therapy were randomized to receive either gilteritinib or salvage chemotherapy in a 2:1 ratio. The co-primary endpoints of the trial were OS and complete remission (CR)/complete remission with partial hematologic recovery (CRh).

Findings from the study showed the median OS for patients who received Xospata was 9.3 months compared with 5.6 months for patients who received salvage chemotherapy (hazard ratio 0.64 (95% CI 0.49, 0.83), P =.0004). The CR/CRh rate in the gilteritinib arm was 22.6% (55/243) and the duration of response was 7.4 months (range: <0.1+ to 23.1+). For patients who achieved a CR/CRh, the median time to first response was 2 months (range: 0.9 to 9.6 months).

“The ADMIRAL trial’s overall survival (OS) findings are encouraging for patients and families impacted by relapsed/refractory FLT3 mutation-positive AML,” said Alexander Perl, MD, Abramson Cancer Center, University of Pennsylvania. “The data underscore the importance of single-agent Xospata for this patient population that, until recently, had few remaining treatment options.”

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Xospata is indicated for the treatment of adults who have relapsed or refractory AML with an FLT3 mutation as detected by an FDA-approved test.

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