The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Eli Lilly’s Jaypirca, a treatment for adults with chronic lymphocytic leukemia (CCL).¹ The recommendation is for use across all lines of therapy, regardless of BTK inhibitor treatment.

In a press release, Paolo Ghia, M.D., 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."

In the same press release, Lilly Oncology’s president and Lilly executive vice president Jacob Van Naarden added, “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."

Earlier this month, Eli Lilly announced results from the Phase 3 BRUIN CLL-322 clinical trial,² which tested Jayprica’s effectiveness in patients with CLL/SLL when paired with venetoclax and rituximab. According to the company, the study results showed that the combination saw a reduction of disease progression or death by 45%.

In a press release, the study’s lead author Matthe S. Davids, MD, MMSc (chief of the division of lumphoma at Dana-Farber Cancer Institute) said, “These results from BRUIN CLL-322 show that the addition of pirtobrutinib as part of a time-limited regimen further enhanced an already effective treatment and extended the duration of remission for patients with previously treated CLL. Importantly, the study provides the first robust evidence for such an approach in patients who received a prior BTK inhibitor. Time-limited regimens are an important option in CLL care and provide patients with meaningful treatment-free intervals. In the context of the modern CLL treatment landscape, where many patients may only receive two lines of therapy, these results speak to the potential benefits that improving second-line therapy can have. Our study has the potential to establish a new standard of care in this population."

In the same press release, Naarden added, “These remarkable findings support the potential addition of two years of Jaypirca to a time-limited venetoclax-based regimen in relapsed or refractory CLL. BRUIN CLL-322 enrolled a mostly covalent BTK inhibitor-pretreated population, ensuring that these results have applicability to the modern CLL treatment landscape where covalent BTK inhibitor use is now common. Additionally, these data further strengthen the unique body of evidence for Jaypirca across the CLL continuum, from monotherapy to combination therapy and across multiple settings where CLL patients need effective treatment."

Sources

1. Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy. Eli Lilly. June 26, 2026. https://www.prnewswire.com/news-releases/lillys-jaypirca-pirtobrutinib-recommended-by-chmp-for-approval-in-the-european-union-for-adults-with-chronic-lymphocytic-leukemia-cll-across-all-lines-of-therapy-302811781.html
2. Lilly's Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax time-limited regimen in people with previously treated CLL/SLL. Eli Lilly. June 14, 2026. https://www.prnewswire.com/news-releases/lillys-jaypirca-pirtobrutinib-significantly-reduced-the-risk-of-disease-progression-or-death-by-45-when-added-to-a-venetoclax-time-limited-regimen-in-people-with-previously-treated-cllsll-302799348.html