IWILFIN eflornithine

Drug Class

Ornithine decarboxylase (ODC) inhibitor

Mechanism

Irreversibly inhibits ornithine decarboxylase, blocking the synthesis of polyamines required for tumor cell survival and cell-cycle progression.

Approved Indication

FDA-approved to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to multiagent, multimodality therapy.

What This Means For Patients

IWILFIN is an oral maintenance therapy designed to prevent recurrence in high-risk neuroblastoma. It is approved by the FDA and is available under the special import policy in Boao Lecheng.

Regulatory Approvals

• FDA — approved (2023) — source

Pivotal Clinical Evidence

• Study 3b — Sholler et al., J Clin Oncol 2023 (NCT02395666) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-eflornithine-reduce-risk-relapse-pediatric-and-adult-patients-high-risk-neuroblastoma