The US Food and Drug Administration approved pirtobrutinib (Jaypirca) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)with no known 17p deletion.
The FDA approval is based on results from the primary analysis of the BRUIN CLL-313 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. Results demonstrated a significant improvement in progression-free survival for the pirtobrutinib arm compared to the control arm, with a hazard ratio of 0.20 and a median follow-up of 28 months, according to the press release by Eli Lilly and Company, the therapy’s manufacturer.
“This approval is grounded in data from BRUIN CLL-313, which showed a significant delay in disease progression for pirtobrutinib compared to chemoimmunotherapy, along with safety and tolerability consistent with its established profile,” said Jennifer A. Woyach, MD, professor, hematologist-oncologist, and director of the Division of Hematology at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Doctors can now consider pirtobrutinib for appropriate patients when initial therapy is needed, not just later in a patient’s treatment journey. Given the efficacy and tolerability of modern targeted therapies – coupled with factors like age or comorbidity – many people diagnosed with CLL or SLL today may only receive one or two lines of therapy, making initial treatment choices critically important.”
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