Eli Lilly shares rise after EU panel backs expanded use of Jaypirca Proactive uses images sourced from Shutterstock
Eli Lilly and Co (NYSE:LLY) shares climbed nearly 6% on Friday after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Jaypirca (pirtobrutinib) for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy.
The positive opinion covers patients regardless of prior treatment with Bruton tyrosine kinase (BTK) inhibitors and marks a step toward broader availability of the drug in the European Union. The recommendation will now be reviewed by the European Commission, which is expected to issue a final decision within one to two months.
The CHMP opinion was supported by data from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 studies. Lilly said BRUIN CLL-313 was the first Phase 3 trial to evaluate a non-covalent BTK inhibitor exclusively in previously untreated CLL patients, while BRUIN CLL-314 was the first Phase 3 study to compare non-covalent and covalent BTK inhibitors in the treatment-naïve setting.
Results from both studies were presented at the 2025 American Society of Hematology Annual Meeting and later published in The Journal of Clinical Oncology.
Jaypirca is already approved in certain markets for other blood cancer indications. Lilly has also submitted the CLL data to the US Food and Drug Administration, with a regulatory decision expected in the second half of 2026.
If approved by the European Commission, the expanded indication would allow Jaypirca to be used as a treatment option for CLL patients throughout the European Union regardless of disease stage or prior BTK inhibitor exposure.
“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,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology.
“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.