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# Lilly’s Jaypirca Shows Major Benefit in Leukemia Trial
- URL: https://www.fdaweb.com/lillys-jaypirca-shows-major-benefit-in-leukemia-trial/
- Published: 2025-09-08T12:00:00.000Z
- Updated: 2026-09-14T15:21:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159827

Eli Lilly’s Bruton tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to topline results from a Phase 3 study. The company says the BRUIN CLL-313 trial compared pirtobrutinib to chemoimmunotherapy with bendamustine plus rituximab in 282 patients without 17p deletions. The study met its primary endpoint, with investigators calling the results “one of the most compelling effect sizes ever observed” for a single-agent BTK inhibitor in front-line CLL.

Overall survival data are not yet mature but are trending in favor of pirtobrutinib, with a definitive analysis expected in 2026, Lilly says, adding that the safety profile was consistent with earlier studies.

The findings mark the third positive Phase 3 readout for the drug in CLL. Lilly said data from trial and the recently announced BRUIN CLL-314 trial — which compared pirtobrutinib head-to-head with ibrutinib — will support regulatory submissions later this year, aimed at expanding Jaypirca’s label into earlier treatment settings.

Jaypirca, a first-in-class non-covalent (reversible) BTK inhibitor, is already approved for relapsed or refractory mantle cell lymphoma and CLL/SLL in patients previously treated with BTK and BCL-2 inhibitors, under FDA’s accelerated approval pathway.