In early March, the National Medical Products Administration approved Jaypirca® (pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib). Pirtobrutinib received approval from the U.S. FDA in January 2023 as a non covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor.
The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL 321 study. BRUIN CLL 321 is the world’s first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator’s choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab). The results demonstrated that pirtobrutinib significantly prolonged median progression free survival (PFS) compared with the investigator’s choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.
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Post time: Mar-12-2026