Acalabrutinib monotherapy (continuous, ACE-LY-004) — r/r MCL
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-ACALABRUTINIB |
|---|
| ID | REG-ACALABRUTINIB-MCL |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-MCL-2024 SRC-NCCN-BCELL-2025 |
Notes
ACE-LY-004 trial (Wang 2018, follow-up 2020): r/r MCL after ≥1 prior line — ORR 81%, CR 40%, mDOR ~26 mo, mPFS ~22 mo. FDA- approved for r/r MCL after ≥1 prior line. Substantial cardiac- safety advantage over ibrutinib (afib ~3% vs ~7-15%). Preferred cBTKi for MCL when accessible — particularly for older patients with cardiac history, hypertension, or anticoagulation. Funding pathway must be confirmed; ibrutinib + R fallback if acala access blocking.
Used By
Indication
IND-MCL-2L-ACALABRUTINIB- IND-MCL-2L-ACALABRUTINIB