Eli Lilly announced updated clinical data from Phase 1/2 trial of pirtobrutinib

Eli Lilly and Company announced updated clinical data from the international Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent Bruton’s tyrosine kinase inhibitor, in adult patients with a range of B-cell malignancies. These data, which were presented in oral and poster presentations at the 65th American Society of Hematology Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma and mantle cell lymphoma. The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity. “Following the two FDA accelerated approvals for pirtobrutinib in 2023, we are excited to present these data at ASH, further building the body of evidence for this medicine in CLL, SLL, MCL, and other B-cell malignancies,” said David Hyman, M.D., chief medical officer, Lilly. “These data support the potential role that pirtobrutinib, the first and only FDA-approved non-covalent BTK inhibitor, can play in extending the time patients may benefit from BTK inhibition therapy and provide additional efficacy data in patients previously treated with a covalent BTK inhibitor. We look forward to expanding our understanding of the broader potential clinical utility of pirtobrutinib as we continue to progress our series of randomized Phase 3 studies in CLL, SLL, and MCL.”