IDHIFA enasidenib

Drug Class

IDH2 inhibitor

Mechanism

Inhibits mutant IDH2 proteins to decrease 2-hydroxyglutarate (2-HG) levels and restore normal myeloid cell differentiation.

Approved Indication

Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

What This Means For Patients

IDHIFA 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 (2017) — Sources

Pivotal Clinical Evidence

• AG221-C-001 — Stein et al., Blood 2017 (NCT01915498) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209607lbl.pdf