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# Lilly’s Jaypirca Gains OK in Leukemia/Lymphoma
- URL: https://www.fdaweb.com/lillys-jaypirca-gains-ok-in-leukemia-lymphoma/
- Published: 2023-12-04T12:00:00.000Z
- Updated: 2026-09-14T14:17:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155909

FDA has granted Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. The approval was based on overall response rate and duration of response from the Phase 1/2 BRUIN trial. Earlier this year, FDA gave the drug accelerated approval for treating relapsed or refractory mantle cell lymphoma patients who have had at least two lines of systemic therapy, including a BTK inhibitor.

Lilly describes Jaypirca as the only FDA-approved non-covalent (reversible) BTK inhibitor, a highly selective kinase inhibitor that can extend the benefit of targeting the BTK pathway in CLL/SLL patients. “Jaypirca utilizes a novel binding mechanism and has the largest body of evidence of any targeted therapy in patients previously treated with a BTK inhibitor,” the company says. The FDA-approved labeling contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.

Lilly says it has a confirmatory study, BRUIN CLL-321, underway and it has reached its target number of progression-free survival events and met its primary endpoint. Topline results were shared with the agency last month and the company says it is awaiting a formal review.