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
News related to:Eli Lilly and Company · 3 min read
INDIANAPOLIS, Oct. 2, 2026 /CourierPR/ -- Eli Lilly and Company today announced that the 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.
The FDA approval is grounded in data from the BRUIN CLL-313 clinical trial, which showed a significant delay in disease progression for pirtobrutinib compared to chemoimmunotherapy, along with safety and tolerability consistent with its established profile. The trial, which was the first prospective, randomized 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, was presented at the American Society of Hematology Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology.
In BRUIN CLL-313, at a median follow-up of 28 months, the primary endpoint of Independent Review Committee (IRC)-assessed progression-free survival (PFS) was significantly improved with pirtobrutinib (n=141) compared to bendamustine plus rituximab (BR) (n=141) (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001), and the median PFS was not yet reached for pirtobrutinib compared to 33.5 months for BR. IRC-assessed overall response rate (ORR) was 94% (95% CI, 89-98) in the pirtobrutinib arm (complete response [CR]=13%; partial response [PR]=81%) and 81% (95% CI, 73-87) in the BR arm (CR=21%; PR=60%). In the BRUIN CLL-313 trial, adverse reactions (ARs) led to dose reductions in 3.6% and permanent discontinuation of Jaypirca in 4.3% of patients. Serious ARs occurred in 28% of patients who received Jaypirca. Serious ARs including pneumonia occurred in 5% of patients.
Jaypirca, the first-and-only FDA-approved non-covalent BTK inhibitor, is a highly selective kinase inhibitor that utilizes 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 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.
Jaypirca is the first-and-only non-covalent BTK inhibitor recommended by the National Comprehensive Cancer Network® (NCCN®). It is Category 2A recommended for treatment-naïve adult patients with CLL/SLL without del(17p), recommended for older patients with cardiac comorbidities who may only need one lifetime treatment for CLL/SLL, and is a Category 1 preferred option for adult patients with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor. Details on the trials can be found by visiting clinicaltrials.gov.
Jaypirca is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor, adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion, and adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. Jaypirca is indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. 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.
Jaypirca is the first-and-only non-covalent BTK inhibitor recommended by the National Comprehensive Cancer Network® (NCCN®). It is Category 2A recommended for treatment-naïve adult patients with CLL/SLL without del(17p), recommended for older patients with cardiac comorbidities who may only need one lifetime treatment for CLL/SLL, and is a Category 1 preferred option for adult patients with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor. Details on the trials can be found by visiting clinicaltrials.gov.
Jaypirca is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor, adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)