Core Viewpoint - The approval of the new indication for the non-covalent BTK inhibitor, Pirtobrutinib (捷帕力®), by the NMPA represents a significant advancement for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously undergone systemic treatment including BTK inhibitors [1][2] Group 1: Product Approval and Mechanism - Pirtobrutinib has been approved for use in adult CLL/SLL patients who have received at least one systemic treatment including a BTK inhibitor [1] - It is a highly selective kinase inhibitor that employs a novel binding mechanism to restore BTK inhibition in patients previously treated with covalent BTK inhibitors [1] - The drug was first approved by the FDA in January 2023 and received approval in China in October 2024 for use in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two systemic treatments [1] Group 2: Clinical Study Results - The approval is based on the results of the international, multicenter, randomized controlled BRUIN CLL-321 Phase III study, which included 238 patients [2] - The study compared the efficacy and safety of Pirtobrutinib monotherapy with either IdelaR or BR regimens in patients previously treated with covalent BTK inhibitors [2] - Results showed that Pirtobrutinib significantly extended the median progression-free survival (PFS) to 14.0 months compared to 8.7 months for the control group, with a hazard ratio (HR) of 0.54, and had a lower treatment-related discontinuation rate of 5.2% versus 21.1% [2] Group 3: Market Impact and Future Plans - The approval of Pirtobrutinib for CLL/SLL in China is a major breakthrough, allowing local patients to benefit from this global innovation [2] - The company aims to leverage its leading brand and expertise in oncology to accelerate the accessibility of this innovative therapy for more cancer patients in need [2]
信达生物(01801)：捷帕力®(匹妥布替尼)在中国获批复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤适应症