The Ministry of Food and Drug Safety on Friday approved the marketing license for Astellas’ Xospata (ingredient: gilteritinib) as the treatment of acute myeloid leukemia (AML).
Xospata is an inhibitor of FLT3 gene mutation. The oral agent reduces or inhibits FLT3 tyrosine kinase, which is involved in cancer cell growth.
AML is a blood cancer in which tumor cells appear in the blood or bone marrow. It occurs mainly in adults, and about one-third of AML patients have an FLT3 gene mutation.
Generally, 60 to 80 percent of AML gets cured by chemotherapy, but up to 50 percent of AML patients who have reached complete remission experience relapse. Patients with FLT3 mutation have a lower survival rate, a poor prognosis, and frequent relapses, compared to those without it.
The approval was based on the phase-3 ADMIRAL study, which showed that Xospata-treated patients had a significant increase in overall survival and a high complete remission rate, compared to salvage chemotherapy.
The median overall survival for patients who received Xospata was 9.3 months, compared with 5.6 months for patients who received salvage chemotherapy. This means that Xospata lowered the risk of death by 36 percent. The rate of complete remission (CR) or complete remission with partial hematologic recovery (CRh) was 34 percent in the Xospata group, higher than 15.3 percent in the salvage chemotherapy group.
The event-free survival, which was the secondary endpoint, was 2.8 months in Xospata-treated patients, which was also 0.7 months longer than that of the salvage chemotherapy group.
The most common adverse reactions of Xospata were anemia (47.2 percent), febrile neutropenia (46.7%), and fever (42.7 percent). The incidence of severe adverse events at Grace 3 or above was lower than those of the salvage chemotherapy group.
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