Xospata gets positive CHMP opinion

Following FDA approval of Astellas’ Xospata (gilteritinib) last year, the EMA’s Committee for Medical Products for Human Use has given a positive recommendation to the FLT3 inhibitor for use as a monotherapy in the treatment of relapsed or refractory acute myeloid leukemia with FLT3 mutation. The recommendation came on the back of results from the phase 3 ADMIRAL trial comparing Xospata with salvage chemotherapy where patients being treated with Xospata achieved significantly longer overall survival versus salvage chemotherapy at 9.3 months and 5.6 months respectively. The one-year survival rates were 37% and 17% respectively.
Astellas’ Andrew Krivoshik, senior vice president and global therapeutic area head, oncology development, said: “There is a high unmet need in AML and Astellas is committed to improving treatment options. Xospata offers a potential new alternative for patients with relapsed or refractory FLT3-positive AML, with data showing improved survival outcomes.”