FDA Approves Addition of Overall Survival Data in Giliterinib Labeling for AML


Gilteritinib (Xospata, Astellas Pharma) is indicated for adults with relapsed/refractory acute myeloid leukemia with an FMS-like tyrosine kinase 3 mutation.

Officials with the FDA approved the addition of overall survival (OS) data in labeling for gilteritinib (Xospata, Astellas Pharma), which is indicated for adults with relapsed/refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation, according to a press release.

The approval was based on final analysis data from the ADMIRAL clinical trial, which included 371 adults with relapsed/refractory AML having a FLT3, ITD, D835, or I836 mutation as detected by an FDA-approved test. The data showed improvement in OS in patients treated with 120 mg gilteritinib monotherapy compared with salvage chemotherapy. Salvage chemotherapy included either intensive cytotoxic chemotherapy or a low-intensity regimen.

For the study, patients were randomized to receive gilteritinib 120 mg once daily over continuous 28-day cycles or prespecified salvage chemotherapy. Results from the trial demonstrated that the median OS for patients who received gilteritinib was 9.3 months compared with 5.6 months for those who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83, P=0.0004). According to the data, the results were consistent in the intensive chemotherapy stratum (HR 0.66; 95% CI: 0.47-0.93) and the low-intensity regimen (HR 0.56; 95% CI: 0.38-0.84).

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

The FDA’s initial approval of gilteritinib in November 2018 was based on an interim analysis of the rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh); the duration of CR/CRh (DOR); and the rate of conversion from transfusion dependence to transfusion independence.

The most frequent adverse effects that occurred in at least 20% of patients receiving gilteritinib were 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.

A version of this article was originally published by Specialty Pharmacy Times.


US FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA (gilteritinib) [news release]. Astellas Pharma. https://newsroom.astellas.us/2019-05-30-U-S-FDA-Approves-Supplemental-New-Drug-Application-Adding-Overall-Survival-Data-for-XOSPATA-R-gilteritinib. Accessed May 30, 2019.

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