Olutasidenib

(Rezlidhia®)

Olutasidenib

Drug updated on 12/11/2024

Dosage FormCapsule (oral; 150 mg)
Drug ClassIsocitrate dehydrogenase-1 (IDH1) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

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Summary
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  • This summary is based on the review of two randomized controlled trial(s). [1-2]
  • In relapsed/refractory acute myeloid leukemia (AML), monotherapy with Olutasidenib resulted in an overall response of 41% (95% confidence cnterval (CI) 21-64), while combination therapy with Azacitidine led to a higher overall response of 46% (95% CI 27-67). Among treatment-naive AML patients, overall response rates were 25% (95% CI 1-81) with monotherapy and 77% (95% CI 46-95) with combination therapy.
  • In relapsed/refractory gliomas with the IDH1R132X mutation, Olutasidenib monotherapy demonstrated a disease control rate of 48%, including an 8% partial response rate (2 patients) and 32% (8 patients) achieving stable disease for at least 4 months.
  • AML and myelodysplastic syndromes (MDS): Common Grade 3-4 treatment-emergent adverse events for monotherapy included thrombocytopenia (28%), febrile neutropenia (22%), and anemia (22%). For combination therapy, thrombocytopenia (41%), febrile neutropenia (28%), neutropenia (28%), and anemia (20%) were reported. Mortality rates were 34% in monotherapy and 20% in combination therapy, primarily due to disease progression, with no deaths considered study-drug related.
  • Relapsed/Refractory Gliomas: Common Grade 3-4 adverse events included increased alanine aminotransferase (12%) and increased aspartate aminotransferase (12%). No dose-limiting toxicities were observed.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Rezlidhia (olutasidenib) Prescribing Information.2024Rigel Pharmaceuticals, Inc., South San Francisco, CA

Randomized Controlled Trials