China approves Jaypirca for chronic lymphocytic leukaemia treatment indications
Healthcare regulator National Medical Products Administration approved Innovent Biologics drug Jaypirca for treating chronic lymphocytic leukaemia and small lymphocytic lymphoma across all lines of therapy in China
China's National Medical Products Administration (NMPA) has granted approval for Jaypirca, a non-covalent Bruton tyrosine kinase (BTK) inhibitor, to be used as a monotherapy for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This decision expands Jaypirca's indications to encompass patients with CLL/SLL across all treatment stages, regardless of prior exposure to covalent BTK inhibitors.
The approval is validated by the results of the global Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials. The BRUIN CLL-313 study revealed a statistically significant improvement in progression-free survival for pirtobrutinib compared to bendamustine plus rituximab in treatment-naïve patients. BRUIN CLL-314, the first head-to-head trial comparing covalent and non-covalent BTK inhibitors in a BTK inhibitor-naïve population, demonstrated noninferiority for overall response rate in both ITT and previously treated patients, with numerically higher ORR than ibrutinib.
Prof. Jianyong Li, Principal Investigator of the BRUIN CLL-313 Study in China, emphasized that pirtobrutinib has demonstrated meaningful clinical benefits in both previously treated and treatment-naïve patients with CLL/SLL. Prof. Luqiu Qiu, Principal Investigator of the BRUIN CLL-314 Study, highlighted the novel head-to-head evidence of pirtobrutinib against a covalent BTK inhibitor in a BTK inhibitor-naïve population.
Dr. Hui Zhou, Chief R&D Officer of Innovent, and Dr. Li Wang, Lilly Corporate Senior Vice President, expressed their commitment to accelerating patient access to this innovative therapy and advancing the management of CLL/SLL in China.
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