艾黎·礼来公司（Lilly）开发的Pirtobrutinib（JaypircaTM）是一种高度选择性、非共价、可逆的布鲁顿酪氨酸激酶（BTK）抑制剂，用于治疗B细胞白血病和淋巴瘤。2023年1月，美国批准了Pirtobrutinib加速批准路径，用于治疗至少接受过两个系统治疗方案（包括BTK抑制剂）后复发或难治性幔细胞淋巴瘤（MCL）的成年患者。该适应症批准基于反应率的加速批准，持续批准可能取决于确认性试验中的临床受益验证和描述。本文总结了Pirtobrutinib开发中的里程碑，以此为基础，首次批准治疗复发或难治性MCL成年患者。 ©2023.作者，独家许可Springer Nature Switzerland AG。

Pirtobrutinib (JaypircaTM), a highly selective, non-covalent, reversible Bruton's tyrosine kinase (BTK) inhibitor, is being developed by Eli Lilly and Company (Lilly) for the treatment of B-cell leukemias and lymphomas. In January 2023, pirtobrutinib was approved in the USA under the Accelerated Approval pathway for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This article summarizes the milestones in the development of pirtobrutinib leading to this first approval for the treatment of adult patients with relapsed or refractory MCL.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.