Rezlidhia (olutasidenib) is now available for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by a test approved by the US Food and Drug Administration (FDA).
The FDA’s approval of olutasidenib was based on data from an open-label, single-arm clinical trial (ClinicalTrials.gov Identifier: NCT0271957) that included 147 patients with relapsed or refractory AML and an IDH1 mutation confirmed through testing.
Findings from the trial showed that olutasidenib met the primary endpoint. The rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 35%. The median duration of CR/CRh was 25.9 months.
Rezlidhia is supplied as 150 mg capsules in 30-count bottles. The wholesale acquisition cost has been set at $32,200 per month.
Patients should be selected for treatment based on the presence of IDH1 mutations in blood or bone marrow. The FDA has approved the Abbott RealTime IDH1 Assay to select patients for Rezlidhia treatment.
To assist with access to Rezlidhia, Rigel Pharmaceuticals has established the Rigel Onecare® patient support center. A nurse navigator will be assigned to patients to assess each individual case.
- Rigel announces availability of Rezlidhia™ (olutasidenib) in the US for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation. News release. Rigel Pharmaceuticals. Accessed December 22, 2022. https://www.prnewswire.com/news-releases/rigel-announces-availability-of-rezlidhia-olutasidenib-in-the-us-for-the-treatment-of-adult-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-with-a-susceptible-idh1-mutation-301708714.html.
- Rezlidhia. Package insert. Rigel Pharmaceuticals; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf.
This article originally appeared on MPR