Lilly's Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, receives expanded indication from U.S. FDA for certain patients with previously untreated CLL/SLL
Key Highlights
- ➤FDA approved Jaypirca (LLY) for previously untreated CLL/SLL without known 17p deletion
- ➤Jaypirca demonstrated significantly improved progression-free survival versus bendamustine plus rituximab
- ➤BRUIN CLL-313 reported PFS hazard ratio of 0.20 at 28-month median follow-up
- ➤Jaypirca becomes a first-line treatment option for appropriate CLL/SLL patients
Expert Statements
Jennifer A. Woyach, 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
“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.”
Jennifer A. Woyach, 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.”
Jennifer A. Woyach, 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
“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.”
Lilly's Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, receives expanded indication from U.S. FDA for certain patients with previously untreated CLL/SLL PR Newswire
INDIANAPOLIS, Oct. 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) (https://edge.prnewswire.com/c/link/?t=0&l=en&o=4786056-1&h=715560983&u=https%3A%2F%2Fwww.fda.gov%2F&a=U.S.+Food+and+Drug+Administration+(FDA)) has approved an additional indication for 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 leukemia 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.
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