The China National Medical Products Administration (NMPA) has approved pirtobrutinib (Jaypirca), a noncovalent BTK inhibitor, for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one prior line of therapy including a BTK inhibitor.
The approval is based on the phase 3 BRUIN CLL-321 trial, the first randomized study in patients pretreated with a covalent BTK inhibitor. Pirtobrutinib monotherapy significantly prolonged progression-free survival versus investigator’s choice (idelalisib plus rituximab; [IdelaR] or bendamustine plus rituximab; [BR]), with lower discontinuation due to treatment-related adverse events.
The phase 3 BRUIN CLL-321 trial randomized 238 previously treated patients to pirtobrutinib monotherapy or investigator’s choice of IdelaR or BR. Pirtobrutinib significantly prolonged progression-free survival and showed lower discontinuation due to treatment-related adverse events, supporting better efficacy and tolerability in patients pre-treated with a covalent BTK inhibitor, according to a press release by Innovent Biologics, Inc, the manufacturer of the therapy.
This is the second indication for pirtobrutinib in China, following prior approval in relapsed/refractory CLL/SLL.
