RT Book, Section
A1 Seung, Amy Hatfield
A1 Dabb, Alix
A2 DiPiro, Joseph T.
A2 Talbert, Robert L.
A2 Yee, Gary C.
A2 Matzke, Gary R.
A2 Wells, Barbara G.
A2 Posey, L. Michael
SR Print(0)
ID 1167563380
T1 Acute Leukemias
T2 Pharmacotherapy: A Pathophysiologic Approach, 10e
YR 2017
FD 2017
PB McGraw-Hill Education
PP New York, NY
SN 9781259587481
LK accesspharmacy.mhmedical.com/content.aspx?aid=1167563380
RD 2024/04/25
AB Content  UpdateNovember  17,  2019Gilteritinib  for  Relapsed  or  Refractory  FLT3-Mutated  Acute  Myeloid  Leukemia:  In  November  2018,  the  U.S.  Food  and  Drug  Administration  (FDA)  granted  approval  to  gilteritinib  (Xospata)  for  treatment  of  relapsed  or  refractory  acute  myeloid  leukemia  (AML)  with  an  FLT3  mutation.  Gilteritinib  is  a  highly  selective  FLT3  inhibitor  with  activity  against  both  types  of  FLT3  mutations.  FDA  approval  was  based  on  an  interim  analysis  of  response  rate  and  duration  of  response  in  the  gilteritinib  arm  of  the  ADMIRAL  trial;  the  results  of  the  phase  3  ADMIRAL  trial  were  recently  published.  Patients  randomized  to  receive  gilteritinib  had  a  higher  complete  remission  rate  and  longer  median  overall  survival  than  patients  who  received  salvage  chemotherapy.  Grade  3  or  higher  adverse  events  occurred  less  frequently  in  the  gilteritinib  group.  Based  on  these  results,  gilteritinib  is  now  an  NCCN  category  1  therapy  for  patients  with  relapsed  or  refractory  AML  with  FLT3  mutation.