Eli Lilly and Company said the U.S. Food and Drug Administration (FDA) approved an additional indication for Jaypirca (pirtobrutinib) in previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without a known 17p deletion. The decision makes Jaypirca, described as the first and only approved non-covalent Bruton tyrosine kinase (BTK) inhibitor, available as a first-line treatment for appropriate patients. In the Phase 3 BRUIN CLL-313 trial, pirtobrutinib significantly improved progression-free survival versus bendamustine plus rituximab, with a hazard ratio of 0.20 and median progression-free survival not yet reached versus 33.5 months. The overall response rate was 94% with pirtobrutinib and 81% with the comparator. Lilly said the safety profile was consistent with earlier trials, while Jaypirca's labeling includes warnings for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity including drug-induced liver injury, and embryo-fetal toxicity. The approval expands Jaypirca's U.S. use beyond its December 2025 indication for relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor.