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China’s NMPA approves pirtobrutinib monotherapy for adults with CLL/SLL
On September 28, 2026, China’s National Medical Products Administration (NMPA) approved pirtobrutinib, a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as monotherapy for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).1 The approval expands the indication of pirtobrutinib to include patients with CLL/SLL across all lines of therapy, regardless of prior covalent BTK inhibitor therapy.1
The approval was supported by results from the phase III BRUIN CLL-313 (NCT05023980) and BRUIN CLL-314 (NCT05254743) trials, which evaluated pirtobrutinib in patients with treatment-naïve and BTK inhibitor-naïve CLL/SLL, respectively.1 In BRUIN CLL-313, pirtobrutinib demonstrated a significant improvement in progression-free survival (PFS) vs bendamustine + rituximab (hazard ratio [HR], 0.20; 95% confidence interval [CI], 0.11–0.37; p < 0.0001), equating to an 80% reduction in the risk of progressive disease or death.1,2 The incidence of Grade ≥3 treatment-emergent adverse events (TEAEs) was 40.0% with pirtobrutinib vs 67.4% with bendamustine + rituximab.2 Similarly, in BRUIN CLL-314, pirtobrutinib demonstrated noninferiority for overall response rate (ORR) vs ibrutinib in the intention-to-treat population (n = 662; 87.0% vs 78.5%; p < 0.0001).3 The incidence of any-grade TEAEs of was similar between pirtobrutinib (97.0%) and ibrutinib (97.8%).3
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In practice, what is the most common reason you discontinue rituximab maintenance after BR in older patients with previously untreated MCL?
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