Rezlidhia olutasidenib

Drug Class

IDH1 inhibitor

Mechanism

Inhibits mutant IDH1 to prevent the accumulation of 2-hydroxyglutarate (2-HG), inducing differentiation of myeloblasts.

Approved Indication

Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

What This Means For Patients

Rezlidhia is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2022) — Sources

Pivotal Clinical Evidence

• 2102-HEM-101 — de Botton et al., Blood Adv 2023 (NCT02719574) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf