The FDA approved Xospata (gilteritinib) for treatment of adult patients with relapsed or refractory acute myeloid leukemia with a certain genetic mutation.
The drug is specifically indicated for a FTL3 genetic mutation as detected by an agency-approved test. The agency also approved an expanded indication for a companion diagnostic to include its use with the leukemia drug.
The agency based its approval on a clinical trial of 138 patients with relapsed or refractory AML and the FLT3 mutation. Of those subjects, 21 percent achieved complete remission, while 31 percent of the 106 requiring transfusions at the beginning of treatment became transfusion-free for at least 56 days.