Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Tibsovo for AML with IDH1 mutation
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation, FDA press release
The Food and Drug Administration has approved ivosidenib (Tibsovo) as the first treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) and an isocitrate dehydrogenase-1 (IDH1) mutation.
More specifically, the oral treatment has been approved for patients whose mutations have been identified by the Abbott RealTime IDH1 assay, a companion diagnostic test.
The approval was based on results from a phase 1, open-label, single-arm, multicenter, dose-escalation and expansion trial of adult patients in this AML population. The primary end point was combined complete remission and complete remission with partial hematologic improvement; this combined rate was 32.8%, and the median duration of this remission was 8.2 months.
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation, FDA press release.
This Week's Must Reads
Must Reads in AML
Immune system changes play a role in AML relapse, Christopher MJ et al. N Engl J Med. 2018 Oct 31. doi: 10.1056/NEJMoa1808777.
Venetoclax plus HMA studied in AML, DiNardo C et al. Blood. 2018 Oct 25. doi: 10.1182/blood-2018-08-868752.
T cell infusion effective in PML, Muftuoglu M et al. N Engl J Med. 2018 Oct 11;379:1443-51
Higher AML, MDS risk linked to autotransplants, Radivoyevitch T et al. Leuk Res. 2018 Jul 19. pii: S0145-2126(18)30160-7
Tibsovo for AML with IDH1 mutation, FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation, FDA press release
