FDA Approves Lilly's Jaypirca as First-Line CLL/SLL Therapy
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.