FDA expands Lilly Jaypirca approval after 80% risk reduction in untreated CLL

The FDA on Oct. 2, 2026 expanded Eli Lilly’s Jaypirca (pirtobrutinib) as first-line treatment for adults with previously untreated CLL or SLL and no known 17p deletion. BRUIN CLL-313, a phase 3 trial of 282 adults, showed an 80% reduction in risk of progression or death versus bendamustine plus rituximab (HR 0.20). Median PFS was not reached with Jaypirca after 28 months’ median follow-up, versus 33.5 months with BR. Response rates were 94% versus 81% overall, 13% versus 21% complete, and 81% versus 60% partial. Dosing is 200 mg orally once daily. Lilly Oncology president Jacob Van Naarden said the milestone underscores versatility across the CLL continuum and has said primary use “remains in second line.” Dr. Jennifer A. Woyach said the approval rests on the trial’s delay in progression with consistent safety, that doctors can consider Jaypirca at initial therapy, and that many patients may get only one or two lines of therapy. CONTESTED: No source disputes the decision or figures. Rated coverage is center and right only.