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News
China's drug regulator approves a next-gen blood cancer drug across all treatment lines. China's NMPA has approved pirtobrutinib (Jaypirca) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), covering all lines of therapy regardless of prior BTK inhibitor use. The decision is backed by strong phase 3 trial data showing a 93.3% overall response rate and a 24-month progression-free survival rate of 93.2% in frontline patients.
China's drug regulator approves a next-gen blood cancer drug across all treatment lines
China's National Medical Products Administration (NMPA) has approved pirtobrutinib (Jaypirca), a non-covalent BTK inhibitor, for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) across all lines of therapy — including those who have previously received covalent BTK inhibitors. The approval is supported by data from two phase 3 trials: BRUIN CLL-313 and BRUIN CLL-314.
In a pooled frontline analysis of 253 treatment-naive patients, pirtobrutinib demonstrated impressive efficacy. In BRUIN CLL-313, it reduced the risk of disease progression or death by 80.1% compared to the chemoimmunotherapy regimen bendamustine plus rituximab. Notably, the European Medicines Agency also recommended EU approval of pirtobrutinib across all CLL therapy lines in June 2026, based on the same trial data.
By the Numbers
Why it matters: This approval expands access to a well-tolerated, next-generation BTK inhibitor for CLL/SLL patients in China across all treatment stages — including those who've exhausted prior BTK inhibitor options — addressing a significant unmet need in a large patient population.
