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Therapy Name Vorasidenib
Synonyms
Therapy Description

Voranigo (vorasidenib) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674). Voranigo (vorasidenib) is FDA-approved for use in adult and pediatric patients 12 years and older with IDH-mutant grade 2 astrocytoma or oligodendroglioma following surgery (FDA.gov)

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Vorasidenib Voranigo AG-881|AG881 IDH Inhibitor (Pan) 3 Voranigo (vorasidenib) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674). Voranigo (vorasidenib) is FDA-approved for use in adult and pediatric patients 12 years and older with IDH-mutant grade 2 astrocytoma or oligodendroglioma following surgery (FDA.gov)

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH2 R172K astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH1 R132L astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... detail... 37272516
IDH2 R172W oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 R132H IDH1 T313I leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and T313I in culture (PMID: 36222845). 36222845
IDH1 R132H high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) treatment decreased brain tumor 2HG levels in an orthotopic glioma cell line xenograft model harboring IDH1 R132H (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH2 act mut astrocytoma, IDH-mutant, grade 3 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 3 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH2 R140Q high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) treatment decreased tumor 2HG levels in a glioma cell line xenograft model harboring IDH2 R140Q (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH2 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 or 3 1p19q codeleted oligodendroglioma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH1 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 or 3 1p19q codeleted oligodendroglioma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH2 R172M oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH2 R172K oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 R132L oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 R132G astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... detail... 37272516
IDH2 R172M astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH1 R132S astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... detail... 37272516
IDH1 R132X astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH1 R132H oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 act mut astrocytoma, IDH-mutant, grade 4 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 4 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 R132C astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH1 R132C fibrosarcoma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) treatment decreased tumor 2HG levels in a fibrosarcoma cell line xenograft model harboring IDH1 R132C (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH1 R132S oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH2 R172X astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH2 mutant low grade glioma predicted - sensitive Vorasidenib Case Reports/Case Series Actionable In a Phase I trial, Voranigo (vorasidenib) treatment resulted in an objective response in 13.6% (3/22, 1 partial response, 2 minor response) and stable disease in 72.7% (16/22) of patients with non-enhancing low-grade glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with a median progression-free survival of 36.8 months, and resulted in stable disease as best response in 56.7% (17/30) of patients with enhancing tumors harboring mutations in IDH1 (n=28) or IDH2 (n=2) (PMID: 34078652; NCT02481154). 34078652
IDH1 R132H IDH1 H315D leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and H315D in culture (PMID: 36222845). 36222845
IDH2 R172S astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH2 R140Q IDH2 E343V leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and E343V in culture (PMID: 36222845). 36222845
IDH2 act mut astrocytoma, IDH-mutant, grade 4 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 4 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH1 act mut astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 act mut astrocytoma, IDH-mutant, grade 3 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 3 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 R132C oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH2 R172G astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 R132X oligodendroglioma sensitive Vorasidenib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH2 R172X oligodendroglioma sensitive Vorasidenib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH1 mutant low grade glioma predicted - sensitive Vorasidenib Phase I Actionable In a Phase I trial, Voranigo (vorasidenib) treatment resulted in an objective response in 13.6% (3/22, 1 partial response, 2 minor response) and stable disease in 72.7% (16/22) of patients with non-enhancing low-grade glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with a median progression-free survival of 36.8 months, and resulted in stable disease as best response in 56.7% (17/30) of patients with enhancing tumors harboring mutations in IDH1 (n=28) or IDH2 (n=2) (PMID: 34078652; NCT02481154). 34078652
IDH2 R172S oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH2 R172G oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516 detail...
IDH2 act mut astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH1 R132G oligodendroglioma sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail... detail...
IDH1 R132H astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... detail... 37272516
IDH2 R140Q IDH2 A347T leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and A347T in culture (PMID: 36222845). 36222845
IDH2 R172W astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). 37272516 detail... detail...

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  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06809322 Phase III Vorasidenib Vorasidenib Maintenance for IDH Mutant Astrocytoma (VIGOR) Not yet recruiting NLD | ITA | GBR | FRA | ESP | DEU | CZE | CHE | BEL | AUT 0
NCT05484622 Phase I Vorasidenib Pembrolizumab + Vorasidenib Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Glioma Recruiting USA 0
NCT02481154 Phase I Vorasidenib Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation Completed USA 0
NCT03343197 Phase I Ivosidenib Vorasidenib Study of AG-120 and AG-881 in Subjects With Low Grade Glioma Completed USA 0
NCT04164901 Phase III Vorasidenib Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) Active, not recruiting USA | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CHE | CAN 1
NCT02492737 Phase I Vorasidenib Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation Completed USA | FRA 0


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