The US Food and Drug Administration (FDA) has approved an additional indication for Eli Lilly and Company’s Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion. This approval allows for the use of Jaypirca as a first-line treatment for appropriate patients.
The labelling for Jaypirca contains warnings and precautions for infections, haemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity including drug-induced liver injury and embryo-foetal toxicity.
Jaypirca, the first-and-only FDA-approved non-covalent BTK inhibitor, is a highly selective kinase inhibitor that utilises a novel non-covalent binding mechanism to target the BTK pathway in patients with CLL/SLL.
The FDA approval is based on results from the primary analysis of a clinical trial, which were presented at the American Society of Hematology Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology.
BRUIN CLL-313 is the first prospective, randomised phase 3 study to examine the efficacy and safety of a non-covalent BTK inhibitor in patients with previously untreated CLL/SLL without 17p deletion.
