Eli Lilly and Company has moved a step closer to expanding the use of its blood cancer therapy Jaypirca (pirtobrutinib) in Europe after receiving a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The recommendation supports the use of the drug for treating adults with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of whether patients have previously received a Bruton tyrosine kinase (BTK) inhibitor.
The positive opinion now advances the application to the European Commission, which has the authority to grant marketing authorization across the European Union. A final regulatory decision is expected within the next one to two months.
If approved, Jaypirca would become available for a broader group of CLL patients, including both newly diagnosed individuals and those who have received previous treatments. The recommendation represents a significant milestone for Lilly as it seeks to expand the global reach of the non-covalent BTK inhibitor.
Chronic lymphocytic leukemia is the most common type of leukemia in adults and is characterized by the slow accumulation of abnormal white blood cells. Although treatment options have improved considerably in recent years, many patients eventually require additional therapies as the disease progresses or becomes resistant to existing treatments. Lilly believes Jaypirca could provide a valuable treatment option throughout the course of the disease.
The CHMP’s recommendation is supported by data from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials, which evaluated the efficacy and safety of pirtobrutinib in patients with chronic lymphocytic leukemia. Results from both studies were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025 and were later published in The Journal of Clinical Oncology.
According to the company, the trials demonstrated strong clinical efficacy along with a favorable tolerability profile, supporting the potential use of Jaypirca across multiple stages of CLL treatment. The studies included patients regardless of previous exposure to BTK inhibitors, reflecting the company’s strategy of positioning the therapy as an option throughout the treatment pathway.
Professor Paolo Ghia of Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele in Milan said the findings from the BRUIN CLL-313 and BRUIN CLL-314 studies provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with chronic lymphocytic leukemia. He noted that the treatment’s combination of efficacy and tolerability highlights its clinical value and said the CHMP’s positive opinion brings the therapy closer to becoming available to more patients across the European Union.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, said the company believes Jaypirca has the potential to become an important treatment option for both newly diagnosed patients and those who have not yet received a BTK inhibitor. He added that advances in CLL treatment mean many patients now receive fewer lines of therapy during their lifetime, making early treatment decisions increasingly important.
Beyond Europe, Lilly is also seeking regulatory approval in the United States. The company has submitted the BRUIN CLL-313 and BRUIN CLL-314 data to the U.S. Food and Drug Administration (FDA) to support approval of Jaypirca for adults with chronic lymphocytic leukemia. A decision from the FDA is expected during the second half of 2026.
With positive regulatory momentum in both Europe and the United States, Lilly is positioning Jaypirca as a potential new standard treatment option for chronic lymphocytic leukemia, aiming to expand access to the therapy for patients across multiple stages of the disease.