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Association details:
| Biomarker: | IDH1 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| Drug: | Tibsovo (ivosidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
10/24/2023
Excerpt:
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test...for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.
Test:
Source:
Published date:
11/10/2023
Excerpt:
Myelodysplastic Syndromes: For mIDH1, added: ivosidenib as a category 2A recommendation.
Source:
Title:
Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)
Published date:
08/15/2023
Excerpt:
Servier...announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for TIBSOVO (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). If approved, TIBSOVO would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset...These findings showed that in the efficacy analysis set (n=18), a complete remission (CR) rate of 38.9% and objective response rate (ORR) of 83.3% were documented in patients treated with TIBSOVO.
Source:
Title:
Combination therapy of the PHD inhibitor molidustat with the IDH1 inhibitor ivosidenib in patients with relapsed/refractory AML or MDS/AML with IDH1 mutation.
Excerpt:
...IDH1-mutated as determined by a validated assay at a specific site (IDH1 R132).4. ...
Trial ID:
Source:
Title:
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Excerpt:
...Have an isocitrate dehydrogenase 1 (IDH1) mutation....
Trial ID:
More C2 evidence
Source:
Title:
Ivosidenib in Mutant IDH1 Relapsed/ Refractory Myelodysplastic Syndrome: Updated Substudy Results
Published date:
09/01/2023
Excerpt:
IVO demonstrated an acceptable safety profile with durable remissions in a substantial proportion of patients with mIDH1 R/R MDS.
Trial ID:
Source:
Title:
UPDATED SUBSTUDY RESULTS FOR IVOSIDENIB IN IDH1-MUTANT RELAPSED/REFRACTORY MYELODYSPLASTIC SYNDROME
Published date:
05/11/2023
Excerpt:
This phase I, open-label multinational substudy is evaluating the safety, tolerability, and clinical activity of IVO in pts with mIDH1 R/R MDS….IVO induced durable remissions, including a substantial proportion of CRs, with an acceptable safety profile in pts with mIDH1 R/R MDS...
Source:
Title:
Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose-escalation and expansion substudy.
Published date:
05/26/2022
Excerpt:
7/16 pts achieved complete response (CR, 44%; 95% CI, 20%, 70%), 1 achieved partial response (6%), and 5 achieved marrow CR (31%), resulting in an ORR of 81% (95% CI, 54%, 96%)...In pts with mIDH1 R/R MDS, IVO monotherapy was tolerable and induced durable remissions and transfusion independence. These findings support the role of IVO as an effective, oral, targeted treatment for pts with mIDH1 R/R MDS.
DOI:
10.1200/JCO.2022.40.16_suppl.7053
Trial ID:
