FDA Approves Pirtobrutinib (Jaypirca) for Previously Untreated CLL/SLL Without 17p Deletion — First Non-Covalent BTK Inhibitor in First Line

On October 2, 2026, the FDA approved Lilly's pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion. Approval rests on the global randomized phase 3 BRUIN CLL-313 trial (282 patients): pirtobrutinib reduced the risk of progression or death by 80% versus bendamustine-rituximab, with median PFS not reached versus 33.5 months and overall response rates of 94% versus 81%. It is the first non-covalent BTK inhibitor approved in the first-line setting.