FDA approves expanded indication for Lilly’s Jaypirca

The FDA has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated CLL or SLL who lack a 17p deletion. The decision is supported by the Phase III BRUIN CLL-313 trial, in which 282 treatment-naive patients received pirtobrutinib or bendamustine plus rituximab; over a median follow-up of 28 months, pirtobrutinib showed a progression-free survival hazard ratio of 0.20, with median PFS not reached versus 33.5 months and an overall response rate of 94% versus 81%. Jaypirca is already listed in NCCN guidelines as a Category 1 preferred option in relapsed or refractory CLL/SLL after prior covalent BTK inhibitor therapy.