FDA expands pirtobrutinib approval to untreated CLL and small lymphocytic lymphoma

The FDA approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion. The FDA announced the approval on October 2, 2026.

The approval was based on BRUIN CLL-313, a randomized trial of 282 patients. After an estimated median follow-up of 28 months, median progression-free survival was not estimable with pirtobrutinib and was 33.5 months with bendamustine plus rituximab. The hazard ratio was 0.20 (95% CI: 0.11, 0.37). The FDA said overall survival data were immature, and median overall survival had not been reached in either group.

Serious adverse reactions occurred in 28% of patients taking pirtobrutinib. The most common non-laboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). The prescribing information warns about infections, bleeding, low blood cell counts, heart rhythm problems, secondary primary malignancies, liver toxicity and embryo-fetal toxicity.