Rezlidhia™ (olutasidenib) is now available for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Olutasidenib is an oral, small molecule inhibitor of mutated IDH1. By inhibiting mutant IDH1, olutasidenib reduces 2-hydroxyglutarate levels and restores normal cellular differentiation of myeloid cells. Approval 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 with an IDH1 mutation confirmed through testing.
Findings from the trial showed that olutasidenib met the primary endpoint with a complete remission (CR) plus a complete remission with partial hematological recovery (CRh) rate of 35% (95% CI, 27-43) and a median duration of CR+CRh of 25.9 months (95% CI, 13.5, not reached).
Rezlidhia is supplied as 150mg 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 olutasidenib.
“We are pleased to launch Rezlidhia today in the US and are ready to provide access to patients,” said Raul Rodriguez, Rigel’s president and CEO. “With durable efficacy data, promising overall survival, and a well characterized safety profile, we are excited to bring Rezlidhia to patients in need.”
To assist with access, the Company 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.