Pirtobrutinib
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | DRUG-PIRTOBRUTINIB |
|---|---|
| Tipo | Fármaco |
| Aliaces | El Sr. JaypircaПіртобрутиніб |
| Situación | reviewed 2026-04-25 | pending_clinical_signoff |
| Enfermedades | DIS-CLL DIS-MCL |
| Fuentes | SRC-NCCN-BCELL-2025 |
Datos sobre drogas
| Clase | 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. |
| Dosificación típica | 200 mg PO una vez al día, continua hasta progresión o toxicidad inaceptable |
| Ucrania registrada | Falso |
| NSZU reembolsado | Falso |
| Ucrania verificada por 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.
Utilizado por
Esquema terapéutico
REG-PIRTOBRUTINIB- Pirtobrutinib en monoterapia (continuo, programa de BRUIN)REG-PIRTOBRUTINIB-MCL- Pirtobrutinib en monoterapia continua (programa de la LCM de BRUIN, post-cBTKi)