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# Lilly’s Jaypirca Wins Approval for Leukemia
- URL: https://www.fdaweb.com/lillys-jaypirca-wins-approval-for-leukemia/
- Published: 2026-10-02T23:34:50.000Z
- Updated: 2026-10-02T23:34:50.000Z
- Author: David McFarland
- Tags: Drugs

FDA has approved Eli Lilly’s Jaypirca (pirtobrutinib) for treating adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.

Approval was based on data from the BRUIN CLL-313 (NCT05023980) trial in 282 patients with previously untreated CLL/SLL without deletion of chromosome 17p. Patients were equally randomized to receive pirtobrutinib until disease progression or bendamustine plus a rituximab product for six cycles, [FDA says](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pirtobrutinib-previously-untreated-chronic-lymphocytic-leukemia-or-small-lymphocytic?ref=fdaweb.com).

“The main efficacy outcome measure was progression-free survival (PFS) as assessed by an independent review committee,” according to the agency. “With an estimated median follow-up for PFS of 28 months, the median PFS was not estimable (NE) (95% CI: NE, NE) in the pirtobrutinib arm and 33.5 months (95% CI: 32.7, NE) in the bendamustine and rituximab arm (Hazard ratio 0.20 \[95% CI: 0.11, 0.37\]; p-value <0.0001). At the time of the primary PFS analysis, overall survival (OS) data was immature. The median OS was not reached in either arm with a total of 13 deaths: three deaths (2.1%) in the pirtobrutinib arm and 10 deaths (7.1%) in the control arm.”

Jaypirca is currently approved to treat specific types of blood cancers, including chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma.