The Food and Drug Administration has approved ivosidenib () 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.
Thewas 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
Inadequate emergency care a challenge for rural pediatric patients, Walling EB et al. J Oncol Pract. 2019 Jan 31. doi: 10.1200/JOP.18.00115.
QC measures improve with CMS Oncology Care Model, Rocque G et al. J Oncol Pract. 2019. doi: 10. 1200/JOP.18.00390.
Women less likely to receive industry funds, Weng JK et al. JAMA Netw Open. 2019 Jan. 25. doi: 10.1001/jamanetworkopen.2018.7377.
A shift in Medicare drug coverage may boost costs for patients, Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.
President Trump requests $500 million for pediatric cancer, Trump D. State of the Union Address, Feb. 5, 2019.
Must Reads in AML
IDH-mutated AML: First-line IDH inhibitors, chemo may up remission, Stein EM et al. ASH 2018, Abstract 560
Rapid genomic results possible, Beat AML trial suggests, Burd A et al. ASH 2018, Abstract 559
Phase 2 results for combo therapy in relapsed AML, Daver N et al. Cancer Discov. 2018 Nov 8. doi: 10.1158/2159-8290.CD-18-0774
Transcription factor networks in AML, Assi SA et al. Nat Genet. 2018 Nov 12. doi: 10.1038/s41588-018-0270-1
Immune system changes play a role in AML relapse, Christopher MJ et al. N Engl J Med. 2018 Oct 31. doi: 10.1056/NEJMoa1808777.