Pirtobrutinib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-PIRTOBRUTINIB |
|---|---|
| Type | Drug |
| Aliases | JaypircaПіртобрутиніб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-CLL DIS-MCL |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Non-covalent (reversible) BTK inhibitor |
|---|---|
| Mechanism | Highly selective non-covalent reversible inhibitor of BTK that binds the kinase via a distinct mechanism not requiring the C481 cysteine residue. Retains activity against BTK-C481S/R mutations that confer resistance to covalent BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib). Preserves activity in TP53-mutated CLL where conventional chemoimmunotherapy fails. |
| Typical dosing | 200 mg PO once daily, continuous until progression or unacceptable toxicity |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Notes
BRUIN trial (Mato 2023): in r/r CLL/SLL after prior cBTKi (median 3 prior lines), ORR 73%; among BTK-C481-mutated subset ORR ~71%. Approved for r/r CLL/SLL after ≥2 prior lines including cBTKi + BCL2i, AND for r/r mantle cell lymphoma after ≥2 prior lines including cBTKi. Distinct binding mechanism overcomes C481-mutated resistance — primary rationale for use. Cardiac safety profile better than ibrutinib (afib ~3% vs 7-15%) but bleeding risk persists. Major UA access barrier: not registered.
Used By
Regimens
REG-PIRTOBRUTINIB- Pirtobrutinib monotherapy (continuous, BRUIN schedule)REG-PIRTOBRUTINIB-MCL- Pirtobrutinib monotherapy continuous (BRUIN MCL schedule, post-cBTKi)