Indianapolis – October 02, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly and Company's Jaypirca (pirtobrutinib), clearing the non-covalent BTK inhibitor as a first-line treatment for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletion.
Phase 3 trial data show an 80% reduction in disease progression risk
The approval rests on the BRUIN CLL-313 trial, which randomized 282 treatment-naïve patients 1:1 to pirtobrutinib or bendamustine plus rituximab (BR) chemoimmunotherapy. At a median follow-up of 28 months, pirtobrutinib cut the risk of disease progression by 80% versus BR (HR=0.20; 95% CI, 0.11–0.37; p0.0001). Median progression-free survival was not yet reached in the pirtobrutinib arm, compared with 33.5 months for BR.
Overall response rate reached 94% for pirtobrutinib versus 81% for BR, with complete response rates of 13% and 21%, respectively. Dose reductions occurred in 3.6% of patients and permanent discontinuations in 4.3%; serious adverse reactions were reported in 28% of patients, most commonly pneumonia at 5%.
Lilly positions Jaypirca across the full CLL treatment continuum
Jaypirca is now the first and only non-covalent BTK inhibitor recommended by the National Comprehensive Cancer Network, carrying a Category 2A recommendation for treatment-naïve CLL/SLL patients without del(17p) and a Category 1 preferred designation for relapsed or refractory patients previously treated with a covalent BTK inhibitor.
"This additional approval for Jaypirca, based on BRUIN CLL-313, marks a significant step forward, expanding its potential to reach more patients who may benefit," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. The drug's labeling carries warnings for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity and embryo-fetal toxicity.
CLL accounts for roughly a quarter of new U.S. leukemia diagnoses
CLL represents about one-quarter of new leukemia cases in the U.S., with approximately 22,760 new diagnoses expected this year. Lilly is advancing four Phase 3 BRUIN trials evaluating pirtobrutinib across multiple CLL/SLL treatment lines, including head-to-head comparisons against covalent BTK inhibitors and venetoclax-based regimens.