Onco Wiki / Regimen

Pirtobrutinib monotherapy (continuous, BRUIN schedule)

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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.

Source YAML: complete record

ComponentsDRUG-PIRTOBRUTINIB
IDREG-PIRTOBRUTINIB
TypeRegimen
Statusreviewed 2026-04-25 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-NCCN-BCELL-2025

Notes

BRUIN trial (Mato 2023): r/r CLL/SLL after prior cBTKi (median 3 prior lines, ~80% with prior cBTKi, ~50% with prior BCL2i) — ORR 73%; in BTK-C481-mutated subset ORR ~71%; mPFS ~19.6 mo. Approved 3L+ post-cBTKi + post-BCL2i in CLL/SLL. Distinct binding mechanism (non-covalent, C481-independent) overcomes resistance to ibrutinib / acalabrutinib / zanubrutinib. Particularly active in TP53-mutated CLL where conventional chemoimmuno + chemoSCT fail.

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Indication