FDA approves pirtobrutinib for previously untreated CLL or SLL
The FDA approved pirtobrutinib (Jaypirca, Eli Lilly and Company) on October 2, 2026 for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. The approval follows the BRUIN CLL-313 trial, which enrolled 282 patients and showed a median progression-free survival that was not estimable versus 33.5 months for bendamustine plus rituximab.
Primary source
FDA approval notification, October 2, 2026
FDA approves pirtobrutinib for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma
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