FDA approves pirtobrutinib for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma
FDA approved Eli Lilly's pirtobrutinib (Jaypirca) on October 2, 2026 for adults with previously untreated CLL or SLL without 17p deletion. In the BRUIN CLL-313 trial of 282 patients randomized to pirtobrutinib or bendamustine plus rituximab, median PFS was not estimable with pirtobrutinib versus 33.5 months in the control arm (hazard ratio 0.20, p<0.0001) at a median follow-up of 28 months. The recommended dose is 200 mg orally once daily until progression or unacceptable toxicity.
Why it matters: FDA approval of pirtobrutinib moves the BTK inhibitor into first-line CLL/SLL treatment based on a 0.20 hazard ratio.