Pirtobrutinib
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| ID | DRUG-PIRTOBRUTINIB |
|---|---|
| Tipo | Fármaco |
| Alegais | JaypircaПіртобрутиніб |
| Estado | reviewed 2026-04-25 | pending_clinical_signoff |
| Doenças | DIS-CLL DIS-MCL |
| Fontes | SRC-NCCN-BCELL-2025 |
Fatos sobre as drogas
| Classe | Non-covalent (reversible) BTK inhibitor |
|---|---|
| Mecanismo | 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. |
| Dose típica | 200 mg PO uma vez por dia, contínua até progressão ou toxicidade inaceitável |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-27 |
Notas
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.
Usado por
Esquema terapêutico
REG-PIRTOBRUTINIB- Pirtobrutinib em monoterapia (continuo, esquema de BRUIN)REG-PIRTOBRUTINIB-MCL- Pirtobrutinib em monoterapia contínua (esquema MCL de BRUIN, pós- cBTKi)