10/05/2026
Exciting news for the CLL community!
The FDA has approved pirtobrutinib (Jaypirca) as a first-line treatment for adults with previously untreated CLL/SLL without a known 17p deletion.
The approval is based on the Phase 3 BRUIN CLL-313 trial, in which pirtobrutinib significantly reduced the risk of disease progression or death compared with bendamustine plus rituximab. After approximately 28 months of follow-up, median progression-free survival had not yet been reached with pirtobrutinib, compared with 33.5 months with chemoimmunotherapy.
This approval brings a non-covalent BTK inhibitor into the frontline setting for the first time, providing another targeted, chemotherapy-free treatment option for people with CLL/SLL.
The FDA has approved pirtobrutinib for the treatment of adult patients with previously untreated CLL or SLL harboring no known 17p deletion.