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 (EC) for final action. The EC's decision is expected in the next 1 to 2 months.

Paolo Ghia, MD, Professor, Medical Oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy, said, "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. 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.

Jacob Van Naarden, Executive Vice President (EVP) and President, Lilly Oncology, said, "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. 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 US Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026.