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Drugs. 2023 Apr;83(6):547-553. doi: 10.1007/s40265-023-01860-1.
Pirtobrutinib (Jaypirca), 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.
派特替尼（Jaypirca），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，由礼来公司（Eli Lilly and Company）研发，用于治疗 B 细胞白血病和淋巴瘤。2023 年 1 月，派特替尼通过加速批准途径在美国获批，用于治疗至少接受过两种系统治疗（包括一种 BTK 抑制剂）后复发或难治性套细胞淋巴瘤（MCL）的成年患者。该适应证的获批是基于缓解率。该适应证的继续批准可能取决于在确证性试验中确认和描述临床获益。本文总结了派特替尼开发过程中的重要里程碑，这些里程碑促成了该药首次获批用于治疗复发或难治性 MCL 的成年患者。
