Eli Lilly's Jaypirca receives FDA approval for untreated CLL and SLL

The U.S. Food and Drug Administration has expanded the label for Eli Lilly and Company’s Jaypirca (pirtobrutinib), approving it as a first-line treatment for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a known 17p deletion.

The decision is based on results from the Phase 3 BRUIN CLL-313 study. In the trial, patients received either 200 mg of pirtobrutinib orally once daily or a combination of bendamustine and rituximab. After a median follow-up of 28 months, the study reported a hazard ratio of 0.20 for disease progression or death, indicating an 80% reduction in risk compared to the chemoimmunotherapy arm. While the median progression-free survival for the Jaypirca group had not yet been reached, the control group showed a median of 33.5 months.

Overall response rates were 94% for the Jaypirca group compared to 81% for the control group, though complete responses were lower in the Jaypirca group at 13% versus 21% for the control. Previously, Jaypirca was only indicated for patients whose cancer had returned or stopped responding to other treatments.