Difference between revisions of "Myelodysplastic syndrome, IDH-mutated"
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Warner-admin (talk | contribs) m (Text replacement - "''NCCN does not have guidelines" to "''NCCN does not currently have guidelines") |
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<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
| − | *[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | + | *[[Ivosidenib (Tibsovo)]] 500 mg PO once per day on days 1 to 28 |
'''28-day cycles''' | '''28-day cycles''' | ||
</div></div> | </div></div> | ||
| + | |||
===References=== | ===References=== | ||
#'''AG120-C-001:''' DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. [https://doi.org/10.1056/NEJMoa1716984 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29860938/ PubMed] [https://clinicaltrials.gov/study/NCT02074839 NCT02074839] | #'''AG120-C-001:''' DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. [https://doi.org/10.1056/NEJMoa1716984 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29860938/ PubMed] [https://clinicaltrials.gov/study/NCT02074839 NCT02074839] | ||
Revision as of 20:50, 3 December 2023
| Section editor | |
|---|---|
 |
Sanjay R. Mohan, MD, MSCI Vanderbilt University Nashville, TN, USA |
Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated MDS, please see the main MDS page for other regimens.
1 regimens on this page
1 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any article published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Myelodysplastic Syndromes.
IDH1 relapsed or refractory
Ivosidenib monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Efficacy |
|---|---|---|---|
| DiNardo et al. 2018 (AG120-C-001) | 2014-2017 | Phase 1/2 (RT) | ORR: 42% |
Biomarker eligibility criteria
- Alteration: IDH1 mutation
References
- AG120-C-001: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. link to original article contains dosing details in abstract PubMed NCT02074839