FDA Approves Drug to Treat Acute Myeloid Leukemia
- By BSTQ Staff
Xospata (gilteritinib) has been approved by the U.S. Food and Drug Administration to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation. The drug is specifically indicated for a FTL3 genetic mutation as detected by an agency-approved test. FDA also approved an expanded indication for a companion diagnostic to include its use with the leukemia drug. Approval is based on a clinical trial of 138 patients with relapsed or refractory AML and the FLT 3 mutation, 21 percent of whom achieved complete remission, and 31 percent of the remaining patients requiring transfusions at the beginning of treatment who became transfusion-free for at least 56 days.
References
FDA Approves Acute Myeloid Leukemia Drug. U.S. Food and Drug Administration press release, Dec. 6, 2018. Accessed at www.fdanews.com/articles/189417-fda-approves-acute-myeloidleukemia-drug?utm_campaign=Drug%20Daily%20Bulletin&utm_source=hs_email&utm_medium=email&utm_content=68097763&_hsenc=p2ANqtz-9RU80TrFNacS5Y2auEDUSAWq3_fA2WZDtK-3Ar-lse0kvNXEk94JQydc9lxl1LARhsYzAE1VJwLXlVR35Cz1mTuNs4OA&_hsmi=68097763.
