Ensartinib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ENSARTINIB |
|---|---|
| Type | Drug |
| Aliases | EnsacoveЕнсартиніб |
| Status | pending_clinical_signoff |
| Diseases | DIS-NSCLC |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Drug Facts
| Class | ALK tyrosine kinase inhibitor (2nd-generation) |
|---|---|
| Mechanism | Oral, second-generation ALK tyrosine kinase inhibitor with activity against ALK rearrangements and several crizotinib-resistance mutations. Also has CNS penetration. Distinct binding mode from alectinib / brigatinib / lorlatinib. |
| Typical dosing | 225 mg PO once daily, with or without food, until disease progression or unacceptable toxicity. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Notes
eXalt3 (NCT02767804): Phase III, treatment-naive ALK-positive advanced NSCLC. Ensartinib vs crizotinib. mPFS 25.8 vs 12.7 mo (HR 0.51). Intracranial response superior to crizotinib. FDA approval Dec 2024 — first-line ALK+ NSCLC. Comparative positioning: alectinib, brigatinib, lorlatinib remain preferred 1L per NCCN/ESMO based on cross-trial PFS and mature CNS data; ensartinib provides additional 2nd-gen option. Distinguishing AE = rash. Trial-source SRC for eXalt3 not yet ingested into KB — FLAG for follow-up.
Used By
Regimens
REG-ENSARTINIB-ALK-1L-NSCLC- Ensartinib monotherapy (eXalt3) — ALK+ NSCLC, 1L metastatic