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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 guideline 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 r/r)	2014-03-12 to 2017-05-08	Phase 1/2 (RT)	ORR: 42%

Biomarker eligibility criteria

Alteration: IDH1 mutation

Targeted therapy

Ivosidenib (Tibsovo) 500 mg PO once per day on days 1 to 28

28-day cycles

References

AG120-C-001 r/r: 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

@@ Line 4: / Line 4: @@
 </div>
 {{#lst:Editorial board transclusions|mpn}}
-<big>'''Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated MDS, please see the [[Myelodysplastic syndrome|main MDS page]] for other regimens.'''</big>
+'''Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated MDS, please see the [[Myelodysplastic syndrome|main MDS page]] for other regimens.'''
 {| class="wikitable" style="float:right; margin-right: 5px;"
 |-
@@ Line 12: / Line 12: @@
 {{TOC limit|limit=3}}
 =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.'''
+'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
-==[https://www.nccn.org/ NCCN]==
+==NCCN==
-*''NCCN does not have guidelines at this granular level; please see [https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf NCCN Guidelines - Myelodysplastic Syndromes].''
+*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1446 NCCN Guidelines - Myelodysplastic Syndromes].''
 =IDH1 relapsed or refractory=
 ==Ivosidenib monotherapy {{#subobject:214f83|Regimen=1}}==
@@ Line 29: / Line 29: @@
 !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 |-
-|[https://doi.org/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001)]
+|[https://doi.org/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001 r/r)]
-|2014-2017
+|2014-03-12 to 2017-05-08
 | style="background-color:#91cf61" |Phase 1/2 (RT)
 | style="background-color:#8c96c6" |ORR: 42%
@@ Line 41: / Line 41: @@
 <div class="toccolours" style="background-color:#b3e2cd">
 ====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'''
 </div></div>
 ===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 r/r:''' 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]
 [[Category:Myelodysplastic syndrome regimens]]
 [[Category:Biomarker-specific pages]]
 [[Category:Bone marrow failure syndromes]]

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