The China National Medical Products Administration (NMPA) has approved pirtobrutinib (Jaypirca), a non-covalent Bruton tyrosine kinase inhibitor, as a monotherapy for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma across all lines of therapy and regardless of prior covalent BTK inhibitor treatment, according to Innovent Biologics, the manufacturer of the drug.
Building upon its previous approval in the relapsed or refractory setting, this expanded indication is based on data from the global phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials. BRUIN CLL-313 demonstrated a statistically significant progression-free survival benefit for pirtobrutinib compared with bendamustine plus rituximab in treatment-naïve patients, while BRUIN CLL-314 met its primary endpoint of non-inferiority for overall response rate compared to a covalent BTK inhibitor, according to a press release by Innovent Biologics.
“This approval has the potential to provide a new option for Chinese patients with CLL/SLL across all lines of therapy, meaningfully advancing the management of CLL/SLL throughout the treatment journey,” according to Prof. Jianyong Li, principal investigator of the BRUIN CLL-313 study in China.
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