Posted from: Wednesday, July 17, 2019 - 08:58 AM - Present

Xospata Label Update Approved

May 30, 2019 – The U.S. FDA has approved a label update for Xospata® (gilteritinib), manufactured by Astellas Pharma. Going forward, the drug’s label will include final analysis data from the ADMIRAL trial. This data demonstrates improved overall survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FMS-like tyrosine kinase 3 (FLT3) mutation who received Xospata as a monotherapy, compared to patients treated with salvage chemotherapy.

AML occurs when the bone marrow produces abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. It is the most common type of acute leukemia diagnosed in adults, and can advance rapidly if untreated. According the American Cancer Society, an estimated 21,450 new cases will be diagnosed in the United States in 2019. An estimated 10,920 individuals will die of the disease.

In the ADMIRAL clinical trial, patients who received Xospata had a median overall survival (OS) of 9.3 months. Patients treated with salvage chemotherapy (chemotherapy used when other treatment options have been unsuccessful) had a median OS of 5.6 months. Recommended dosing is 120mg taken by mouth once daily. There is a black box warning that advises the use of Xospata may cause differentiation syndrome, a serious and potentially fatal condition.

Xospata first received FDA approval in 2018. It is currently indicated only for the treatment of relapsed or refractory AML with an FLT3 mutation detected by an FDA-approved test.

Last Updated Wednesday, October 16, 2019 - 01:55 PM.