This article is more than 5 years old. Information may no longer be current.
FDA approves addition of OS data to Xospata label for FLT3-mutated acute myeloid leukemia
Click Here to Manage Email Alerts
The FDA approved the addition of OS data to the label of gilteritinib, which is indicated for the treatment of adults with relapsed or refractory FLT3-mutated acute myeloid leukemia.
Gilteritinib (Xospata, Astellas Pharma) received FDA approval for this indication in November based on an interim analysis of complete remission/complete remission with partial hematologic recovery, duration of response, and the rate of conversion from transfusion dependence to transfusion independence in the ADMIRAL trial.
Final analysis of the trial — which included 371 adults with relapsed or refractory AML with a FLT3 internal tandem duplication, D835 or I836 mutation as detected by the LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe) — showed improved OS among patients assigned gilteritinib monotherapy vs. salvage chemotherapy.
Researchers randomly assigned patients 2:1 to receive 120 mg gilteritinib once daily over continuous 28-day cycles (n = 247) or salvage chemotherapy with either an intensive cytotoxic chemotherapy or a low-intensity regimen (n = 124).
Median OS was 9.3 months for patients assigned gilteritinib compared with 5.6 months among those assigned chemotherapy (HR = 0.64; 95% CI, 0.49-0.83). Gilteritinib improved survival compared with patients who received the intensive (HR = 0.66; 95% CI, 0.47-0.93) or low-intensity (HR = 0.56; 95% CI, 0.38-0.84) chemotherapy regimens.
“The ADMIRAL trial’s OS findings are encouraging for patients and families impacted by relapsed/refractory FLT3 mutation-positive AML,” Alexander Perl, MD, associate professor of medicine at Abramson Cancer Center of the University of Pennsylvania, said in a press release. “The data underscore the importance of single-agent Xospata for this patient population that, until recently, had few remaining treatment options.”
Common adverse reactions among patients assigned gilteritinib included increased transaminase, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting and renal impairment.
Fatal adverse reactions occurred in 2% of patients receiving gilteritinib, which included cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The label includes a boxed warning regarding the risk for differentiation syndrome, which may be life-threatening without treatment.