FDA Clears IND for TERN-701 for Chronic Myeloid Leukemia
The FDA has cleared an investigational new drug application for TERN-701 as a treatment for patients with chronic myeloid leukemia (CML).
A phase I study will evaluate the safety, efficacy, and pharmacokinetics of TERN-701, an oral, allosteric BCR-ABL tyrosine kinase inhibitor, in patients with chronic myeloid leukemia (CML). The FDA has cleared an investigational new drug (IND) application for TERN-701, enabling the global phase 1 CARDINAL study (NCT05367700) which targets patients who have experienced treatment failure on at least one second‑generation TKI. The study aims to assess dose escalation, safety, and anti‑BCR‑ABL activity across multiple dose cohorts and later evaluate recommended doses in an expansion phase.
This IND clearance paves the way for the first allosteric BCR‑ABL inhibitor to enter clinical development for CML, potentially providing improved safety and efficacy for patients who have become resistant to existing active‑site tyrosine kinase inhibitors.
Evidence level: Feltételezés / hírjelzés. Nincs önálló tudományos bizonyíték.
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