Onco-Summaries: Daily Oncology Updates at a Glance
02/10/2026
US FDA approves Jaypirca for treatment of previously untreated CLL/SLL patients (Ref)
Eli Lilly announced that the US FDA has approved Jaypirca (pirtobrutinib; BTK inhibitor) for adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who do not have a known 17p deletion, expanding the drug's use into the first-line setting
The approval is supported by results from the Phase 3 BRUIN CLL-313 trial, which evaluated Jaypirca versus bendamustine plus rituximab (BR) in previously untreated CLL/SLL patients
Jaypirca reduced the risk of disease progression or death by 80% versus BR (HR=0.20; p<0.0001), with median progression-free survival not reached compared with 33.5 months for BR
Overall response rates were 94% with Jaypirca and 81% with BR
The safety profile was consistent with prior studies, with dose reductions reported in 3.6% of patients and treatment discontinuations in 4.3% of patients
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