Astellas launches AML drug Xospata in the USA

Following swiftly on its late November approval, Japanese drug major Astellas Pharma (TYO: 4503) today announced that Xospata (gilteritinib) is now available for prescription in the USA for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation as detected by a Food and Drug Administration-approved test.

An oral monotherapy, Xospata is the first and only FLT3-targeting agent approved by the FDA for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML. It was launched in Japan earlier this month.

“Astellas aims to pursue cutting-edge science that provides value to patients,” said Mark Reisenauer, senior vice president, oncology business unit, Astellas, adding: “Xospata is an excellent example of how we are continuing to advance on this promise to patients.”