Non-Covalent BTK Drug Wins Broad Approval in Most Common Leukemia
The approval is based on a Phase 3 trial showing pirtobrutinib cut the risk of progression or death by 80%, Lilly said.
- On Friday, October 2, 2026, the U.S. Food and Drug Administration approved Eli Lilly and Company's Jaypirca for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
- As a non-covalent Bruton tyrosine kinase inhibitor, Jaypirca previously held approval for relapsed or refractory CLL/SLL patients treated with covalent BTK inhibitors, now expanding to first-line use for appropriate patients.
- Data from the Phase 3 BRUIN CLL-313 clinical trial demonstrated pirtobrutinib significantly improved progression-free survival compared to bendamustine plus rituximab , achieving a 94% overall response rate in the pirtobrutinib arm versus 81% in the BR arm.
- Expanding treatment options, the company stated, "Doctors can now consider pirtobrutinib for appropriate patients when initial therapy is needed, not just later in a patient's treatment journey." This shifts Jaypirca's role to first-line care.
- The National Comprehensive Cancer Network recommends pirtobrutinib as a Category 2A option for treatment-naïve patients; roughly 23,000 new CLL cases occur annually in the U.S., with about 95% of patients lacking 17p deletion.
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Non-Covalent BTK Drug Wins Broad Approval in Most Common Leukemia
(MedPage Today) -- The FDA on Friday expanded the approval of pirtobrutinib (Jaypirca) in chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) to include the first-line treatment of adults whose cancers have no known 17p deletion...
The Paintsville Herald
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
INDIANAPOLIS, Oct. 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today 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…
FDA approves expanded indication for Lilly's Jaypirca
Jaypirca is a non-covalent Bruton tyrosine kinase (BTK) inhibitor and is administered orally as 50mg or 100mg tablets to achieve a daily 200mg dose. The regulatory decision is The post FDA approves expanded indication for Lilly’s Jaypirca appeared first on Pharmaceutical Business review.
New Leukemia Drug Shows Stunning First-Line Results, but Experts Urge
Chronic lymphocytic leukemia (CLL), the most common leukemia of adults in Western countries, is standing at a genuine regulatory and clinical crossroads. In December 2025, two phase III trials, BRUIN CLL-313 and BRUIN CLL-314, were published back to back and delivered results that many hematologists had been waiting years to see. Pirtobrutinib, a noncovalent inhibitor […]
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