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Pirtobrutinib

Jaypirca · BTKi (non-covalent) · BTK

Mechanism

First non-covalent (reversible) BTK inhibitor. Active against C481S BTK mutations that cause resistance to covalent BTKis.

Indication in MCL

Relapsed/refractory MCL after at least two prior therapies including a covalent BTK inhibitor

Approval Status
FDAApproved (2023-01)R/R MCL after covalent BTKi
Key Trials
BRUIN MCL-321
Related Papers (20)

Dissecting Pirtobrutinib Resistance in Mantle Cell Lymphoma Through Single-Cell Multi-Omics.

American journal of hematology · Apr 2026

Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions.

Leukemia · Apr 2026

Bruton protein-tyrosine kinase (BTK) FDA-approved small molecule inhibitors used for the management of neoplastic and inflammatory disorders.

Pharmacological research · Apr 2026

First Fluorescence Method for Native Quantification of Pirtobrutinib Used for Treatment of Cancer in its Market Form and Biological Fluids; Application of Greenness.

Journal of fluorescence · Feb 2026

Pirtobrutinib in relapsed or refractory mantle cell lymphoma: outcomes from the compassionate use program in Italy.

Leukemia & lymphoma · Jan 2026

Cutaneous Adverse Effects in Patients Treated with BTK Inhibitors.

Cancers · Jan 2026

BTK Inhibition in Hematology: From CLL/SLL to Emerging Applications Across B-Cell and Immune Disorders.

Biomolecules · Jan 2026

A matching-adjusted indirect comparison of survival outcomes with pirtobrutinib (BRUIN) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma previously treated with a covalent Bruton tyrosine kinase inhibitor.

British journal of haematology · Jan 2026

Patient-reported outcomes among patients with mantle cell lymphoma or chronic lymphocytic leukemia receiving pirtobrutinib in the BRUIN phase 1/2 study: final analysis.

Current medical research and opinion · Dec 2025

Bruton Tyrosine Kinase Inhibitors in Mantle Cell Lymphoma: What Are the Current Options?

European journal of haematology · Dec 2025

TCA cycle mode switch determines the fate of pirtobrutinib-tolerant persister cells in mantle cell lymphoma.

Blood · Nov 2025

Treatment and outcomes of progression of disease post-CAR T-cell therapy in mantle cell lymphoma: a multicenter analysis.

Blood advances · Nov 2025

Pirtobrutinib in Chinese patients with relapsed or refractory B-cell malignancies: A single-arm, open-label, phase 2, multicenter trial.

International journal of cancer · Jun 2025

High-Performance Liquid Chromatography-Ultraviolet Assay for the Determination of Pirtobrutinib Levels in a Patient With Mantle Cell Lymphoma.

Biomedical chromatography : BMC · May 2025

From development to clinical success: the journey of established and next-generation BTK inhibitors.

Investigational new drugs · Apr 2025

Development of a novel UHPLC-MS/MS method for quantitative analysis of pirtobrutinib in rat plasma: application to pharmacokinetic study.

BMC chemistry · Feb 2025

Ganciclovir-resistant CMV encephalitis in a mantle cell lymphoma patient on pirtobrutinib: Case report.

IDCases · Jan 2025

Pirtobrutinib monotherapy in Bruton tyrosine kinase inhibitor-intolerant patients with B-cell malignancies: results of the phase I/II BRUIN trial.

Haematologica · Jan 2025

Evaluating pirtobrutinib for the treatment of relapsed or refractory mantle cell lymphoma.

Expert review of hematology · Oct 2024

Pirtobrutinib: A New and Distinctive Treatment Option for B-Cell Malignancies.

The Annals of pharmacotherapy · Oct 2024