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

Eli Lilly and Company 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. 

"Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with CLL across multiple lines of therapy," said Paolo Ghia, M.D., professor, medical oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy. "The strong efficacy and tolerability demonstrated in these trials underscores the clinical value pirtobrutinib may offer patients. This positive opinion from the CHMP is an exciting and significant milestone, bringing us closer to a future where pirtobrutinib is an option for more people with CLL across the European Union."

Results from BRUIN CLL-313 and BRUIN CLL-314 were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology.

"Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important. This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy. Today, we are on the brink of making that a reality across the European Union as we await the European Commission's final decision."

Lilly has also submitted these results to the U.S. Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026.