INDIANAPOLIS, June 26, 2026
Eli Lilly and Company announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Jaypirca (pirtobrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of prior BTK inhibitor treatment. The recommendation is supported by the pivotal Phase 3 BRUIN CLL-313 and BRUIN CLL-314 studies, marking a significant regulatory milestone for Lilly’s oncology portfolio. If approved by the European Commission, Jaypirca would become a new treatment option across the European Union, with a final decision expected within the next one to two months. Lilly has also submitted the same data to the U.S. FDA, with a regulatory decision anticipated in the second half of 2026. The company believes the approval could significantly expand patient access to its non-covalent BTK inhibitor in one of the world’s most common adult leukemias.
Phase 3 BRUIN Studies Demonstrate Strong Clinical Evidence
The CHMP recommendation is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials, which were previously presented at the 2025 American Society of Hematology (ASH) Annual Meeting and published in The Journal of Clinical Oncology. BRUIN CLL-313 became the first Phase 3 study evaluating a non-covalent BTK inhibitor exclusively in treatment-naïve CLL patients, while BRUIN CLL-314 was the first Phase 3 trial to directly compare a non-covalent BTK inhibitor with a covalent BTK inhibitor in patients who had never received BTK inhibitor therapy. According to Lilly, the studies demonstrated strong efficacy, favorable tolerability, and meaningful clinical benefit, reinforcing Jaypirca’s potential as both an early-line and later-line treatment option for adults living with CLL across multiple treatment settings.
Lilly Expands Global Regulatory Strategy for Jaypirca
Lilly executives emphasized that modern CLL treatment has shifted toward earlier use of highly effective targeted therapies, making first-line treatment decisions increasingly important. The company believes Jaypirca’s highly selective, non-covalent BTK inhibition offers physicians greater flexibility while addressing resistance challenges associated with earlier BTK therapies. Beyond Europe, Lilly is pursuing broader global regulatory approvals to position Jaypirca as a treatment option for patients throughout the disease continuum. Jaypirca is already approved in the United States for certain patients with relapsed or refractory CLL/SLL and mantle cell lymphoma, and the latest European recommendation represents another important step in expanding its oncology indications. If the European Commission grants marketing authorization, Jaypirca could become one of the few BTK inhibitors approved for CLL across all lines of therapy in the European Union.
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Growing Demand for Innovative CLL Targeted Therapies
Chronic lymphocytic leukemia (CLL) remains one of the most common adult leukemias, with approximately 100,000 new cases diagnosed globally each year. As treatment strategies increasingly favor targeted therapies over traditional chemotherapy, demand continues to grow for medicines capable of delivering durable responses while maintaining manageable safety profiles. Lilly’s development of Jaypirca (pirtobrutinib) reflects this evolution, focusing on next-generation BTK inhibition designed to overcome treatment resistance and improve long-term disease management. With the positive CHMP opinion now secured and additional regulatory reviews underway, Jaypirca continues to strengthen its position as a promising targeted therapy that could reshape CLL treatment standards across major global markets.
Source: Eli Lilly, press release
