China’s National Medical Products Administration approved Pirtobrutinib (Jaypirca) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This decision follows its earlier approval by the U.S. FDA in December 2025 and offers a new option for patients whose disease progressed after prior covalent BTK inhibitors.
The approval is based on results from the Phase 3 BRUIN CLL-321 trial. In the study, pirtobrutinib was compared with standard chemoimmunotherapy options, including idelalisib plus rituximab or bendamustine plus rituximab. Patients treated with pirtobrutinib had a median progression-free survival of 14.0 months, compared with 8.7 months in the control group. This means a 46% lower risk of disease progression or death. The 18-month overall survival rate was also slightly higher with pirtobrutinib.
Pirtobrutinib showed better tolerability than standard treatments. Only 5.2% of patients stopped treatment due to side effects, compared with 21.1% in the control group. Fewer patients needed dose reductions. Common side effects included anemia, pneumonia, and neutropenia. Pirtobrutinib is a next-generation, reversible BTK inhibitor designed for patients who have already received earlier BTK-targeted therapies.