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Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Lymphocytic lymphoma, Waldestrom’s, and palsmalymphocytic lymphoma are closely related conditions. but ntoothe same. There is no indication for this drug for Waldenstrom’s or its lymphoma equivalent. FDA grantaed an accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Approval was based on BRUIN, a single-arm study of pirtobrutinib monotherapy in patients with B-cell malignancies.
Andrew W. Roberts, Therapeutic development and current uses of BCL-2 inhibition. Hematology Am Soc Hematol Educ Program (2020) 2020 (1): 1–9.
Philip A. Thompson, Constantine S. Tam, Pirtobrutinib: a new hope for patients with BTK inhibitor–refractory lymphoproliferative disorders. Blood (2023) 141 (26): 3137–3142.
Telaraja D, Kasamon YL, Collazo JS, Leong R, Wang K, Li P, Dahmane E, Yang Y, Earp J, Grimstein M, Rodriguez LR, Theoret MR, Gormley NJ. FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma. Clin Cancer Res. 2024 Jan 5;30(1):17-22.
Prescribing Information Jaypirca 2025