Onco-Summaries: Daily Oncology Updates at a Glance

03/12/2025

Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL

Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL (Ref)

The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.

• This approval converted the accelerated approval granted in December 2023 for later-line CLL/SLL to a traditional approval

• Jeff Sharman, Disease Chair, Hematology Executive Committees, SCRI at Willamette Valley Cancer Institute and Research Center, and one of the principal investigators of the BRUIN CLL-321 trial: "Pirtobrutinib is the only medicine in CLL or SLL that has been prospectively studied in a randomized trial of patients previously treated with a covalent BTK inhibitor, and I am excited to see this expanded FDA approval recognize the benefit it can deliver to this broader group of patients.

  
  

  • When covalent BTK inhibitors are no longer an option due to disease progression or intolerance, pirtobrutinib enables physicians to extend the benefits of targeting the BTK pathway, offering continuity in the CLL or SLL treatment experience."