The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical Oncology

BRUIN CLL-313 is the first Phase 3 study to evaluate a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL and BRUIN CLL-314 is the first Phase 3 CLL trial to compare non-covalent and covalent BTK inhibitors, as well as the first to compare any BTK inhibitors in the treatment-naïve setting

If granted marketing authorization, this would expand pirtobrutinib's indication as a treatment option for patients with CLL in the European Union across all lines of therapy

INDIANAPOLIS, June 26, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and regardless of prior BTK inhibitor treatment. Following this positive opinion, the application is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months.