Eli Lilly Wins First-Line FDA Approval for Jaypirca in CLL/SLL

The U.S. Food and Drug Administration (FDA) expanded approval of Eli Lilly’s Jaypirca (pirtobrutinib) as a first-line treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion. Jaypirca is the first and only non-covalent BTK inhibitor approved for this indication.

The approval was based on results from the Phase 3 BRUIN CLL-313 trial. Jaypirca significantly improved progression-free survival compared with standard chemoimmunotherapy using bendamustine plus rituximab.

Jaypirca reduced the risk of disease progression or death by 80% compared with the chemotherapy combination.