EU Regulators Back Lilly’s Jaypirca for Chronic Lymphocytic Leukemia

The recommendation follows clinical data from the BRUIN CLL-313 and BRUIN CLL-314 trials, which were recently published in The Journal of Clinical Oncology. These studies mark a shift in the treatment landscape, as BRUIN CLL-313 evaluated pirtobrutinib in treatment-naïve patients, while BRUIN CLL-314 provided a direct comparison between non-covalent and covalent BTK inhibitors.

Following the CHMP’s endorsement, the application now heads to the European Commission for final marketing authorization, with a decision expected within the next two months. Jacob Van Naarden, executive vice president of Lilly Oncology, noted that the move addresses a critical need for early-line treatment options. If approved, the drug would be available to a broad spectrum of patients in the European Union, including those who have not yet received other BTK inhibitors. Lilly has also submitted the trial results to the U.S. Food and Drug Administration, with a regulatory decision anticipated in the second half of 2026.