Acalabrutinib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ACALABRUTINIB |
|---|---|
| Type | Drug |
| Aliases | CalquenceАкалабрутиніб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-CLL DIS-MCL |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Second-generation BTK inhibitor (selective) |
|---|---|
| Mechanism | Covalent irreversible inhibitor of Bruton's tyrosine kinase (BTK). More selective than ibrutinib for BTK over off-target kinases (TEC, EGFR, ITK) — substantially reduced cardiac (atrial fibrillation), bleeding, and hypertension toxicities while preserving CLL/MCL efficacy. |
| Typical dosing | 100 mg PO twice daily continuous (CLL/MCL/SLL); take with PPI separation (acid-sensitive — 2h apart) |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Notes
Preferred BTKi over ibrutinib in modern CLL/MCL guidelines (ELEVATE-RR for r/r CLL — comparable efficacy, fewer cardiac/hypertension events). ELEVATE-TN: 1L CLL data also favorable. Ukraine: registered but NOT reimbursed via НСЗУ — funding gap; ibrutinib substitution if access blocking. PPI co-administration reduces absorption — separate by 2h or switch to acalabrutinib maleate tablet (PPI-compatible).
Used By
Regimens
REG-ACALABRUTINIB-CONTINUOUS- Acalabrutinib monotherapy (continuous, until progression or intolerance)REG-ACALABRUTINIB-MCL- Acalabrutinib monotherapy (continuous, ACE-LY-004) — r/r MCLREG-ACALABRUTINIB-RITUXIMAB- Acalabrutinib + Rituximab (continuous BTKi + R)REG-AVO-CLL-1L- Acalabrutinib + Venetoclax + Obinutuzumab (AVO), fixed-duration 14 cycles (AMPLIFY)