Eli Lilly and Company said the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Jaypirca (pirtobrutinib), a non‑covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with chronic lymphocytic leukemia across all lines of therapy, regardless of prior BTK inhibitor exposure. Following the opinion, the application moves to the European Commission for a final decision, which Lilly expects within the next one to two months. If granted marketing authorization, the indication would make pirtobrutinib an option for treatment‑naïve patients as well as those previously treated, expanding its use across the full CLL treatment continuum in the European Union.
The CHMP recommendation is based on results from the Phase 3 BRUIN CLL‑313 and BRUIN CLL‑314 trials, which were presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical Oncology. BRUIN CLL‑313 is described as the first Phase 3 study to evaluate a non‑covalent BTK inhibitor exclusively in treatment‑naïve CLL, while BRUIN CLL‑314 is the first Phase 3 CLL trial to compare non‑covalent and covalent BTK inhibitors, and the first to compare any BTK inhibitors in the treatment‑naïve setting. Investigators and Lilly executives said the data demonstrate strong efficacy and tolerability, supporting pirtobrutinib’s potential to provide meaningful benefit across multiple lines of therapy, particularly as many contemporary CLL treatment strategies involve fewer total lines over a patient’s lifetime, making early‑line choices critical.
Lilly noted that it has also submitted the BRUIN CLL‑313 and CLL‑314 results to the U.S. Food and Drug Administration for an expanded CLL indication in adult patients, with a regulatory decision expected in the second half of 2026.
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