FDA approves pirtobrutinib for previously untreated CLL/SLL

On October 2, 2026, the U.S. Food and Drug Administration (FDA) approved pirtobrutinib for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) without del(17p).¹

This approval was supported by results from the phase III BRUIN-CLL-313 trial (NCT05023980) evaluating pirtobrutinib vs bendamustine + rituximab in patients with previously untreated CLL/SLL without del(17p).^1,2 At an estimated median follow-up of 28 months, the median progression-free survival (PFS) with pirtobrutinib was not estimable vs 33.5 months with bendamustine + rituximab (hazard ratio [HR], 0.20; 95% confidence interval [CI], 0.11–0.37; p < 0.0001). Median overall survival (OS) was not reached in either arm.^1,2 There were three deaths in the pirtobrutinib arm and ten deaths in the bendamustine + rituximab arm.^1,2

The most common non-laboratory adverse reactions in patients receiving pirtobrutinib were upper respiratory tract infection (27%), rash (22%), and COVID-19 (21%); serious adverse reactions occurred in 28% of patients.¹

The prescribing information includes warnings and precautions for hemorrhage, infections, cytopenias, cardiac arrhythmias, secondary primary malignancies, hepatotoxicity, and embryo-fetal toxicity.¹