Announcement • 8h
Eli Lilly And Company Receives Positive Opinion From CHMP For Jaypirca For Treatment Of Adults With Chronic Lymphocytic Leukemia Across All Lines Of Therapy
Eli Lilly and Company has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase inhibitor, for the treatment of adults with chronic lymphocytic leukemia across all lines of therapy and regardless of prior BTK inhibitor treatment. The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical Oncology. BRUIN CLL-313 is the first Phase 3 study to evaluate a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL and BRUIN CLL-314 is the first Phase 3 CLL trial to compare non-covalent and covalent BTK inhibitors, as well as the first to compare any BTK inhibitors in the treatment-naïve setting. If granted marketing authorization, this would expand pirtobrutinib's indication as a treatment option for patients with CLL in the European Union across all lines of therapy. The application is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months. Results from BRUIN CLL-313 and BRUIN CLL-314 were presented at the American Society of Hematology Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology. Lilly has also submitted these results to the U.S. Food and Drug Administration for approval for adult patients with CLL, with a decision expected in the second half of 2026. BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (BR) in people with CLL/SLL without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or BR per labeled doses. BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include investigator and IRC assessed ORR, duration of response, and PFS, OS, time to next treatment, safety and tolerability and patient-reported outcomes. BRUIN CLL-314 is a Phase 3, randomized, open-label study of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with CLL/SLL who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial enrolled 662 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is ORR as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed PFS, duration of response and event-free survival, and time to next treatment, OS, safety and tolerability, and patient-reported outcomes. Jaypirca (pirtobrutinib, formerly known as LOXO-305) is a highly selective, non-covalent inhibitor of the enzyme BTK. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma and chronic lymphocytic leukemia. Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity. CLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes. CLL is one of the most common types of leukemia in adults. There are roughly 100,000 new cases of CLL globally each year, and the overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year. In CLL, the cancer cells are present in the blood. Indications for Jaypirca (pirtobrutinib) in the United States include adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor and adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in a confirmatory trial. Important safety information for Jaypirca includes infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity including drug-induced liver injury, embryo-fetal toxicity, and adverse reactions in patients who received Jaypirca. The most common adverse reactions in the pooled safety population of patients with hematologic malignancies were decreased neutrophil count, decreased hemoglobin, decreased leukocytes, fatigue, decreased platelets, decreased lymphocyte count, and calcium decreased. Serious adverse reactions occurred in 38% of patients with mantle cell lymphoma, with pneumonia, COVID-19, musculoskeletal pain, hemorrhage, pleural effusion, and sepsis occurring in 2% or more of patients. Fatal adverse reactions within 28 days of last dose occurred in 7% of patients, most commonly due to infections, including COVID-19. Dose modifications and discontinuations due to adverse reactions included dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Most common adverse reactions and select laboratory abnormalities in mantle cell lymphoma included hemoglobin decreased, platelet count decreased, neutrophil count decreased, lymphocyte count decreased, creatinine increased, fatigue, musculoskeletal pain, calcium decreased, diarrhea, edema, dyspnea, AST increased, pneumonia, bruising, potassium decreased, sodium decreased, lipase increased, ALT increased, potassium increased, alkaline phosphatase increased.