Jaypirca (pirtobrutinib) - (BRUIN CLL-313)

Oct. 2, 2026: Eli Lilly and Company (NYSE: LLY) said the FDA approved an expanded indication for Jaypirca (pirtobrutinib) for adult patients with previously untreated CLL/SLL with no known 17p deletion, allowing first-line use in this population.

The approval was based on the Phase 3 BRUIN CLL-313 trial in previously untreated CLL/SLL without 17p deletion. At a median 28-month follow-up, IRC-assessed progression-free survival significantly favored pirtobrutinib over bendamustine plus rituximab (n=141 per arm), with HR 0.20 (95% CI 0.11-0.37; p<0.0001); median PFS was not reached with pirtobrutinib versus 33.5 months for BR. IRC-assessed ORR was 94% (CR 13%, PR 81%) for pirtobrutinib versus 81% (CR 21%, PR 60%) for BR.

In BRUIN CLL-313, adverse reactions led to dose reductions in 3.6% and permanent discontinuation in 4.3% of Jaypirca-treated patients; serious adverse reactions occurred in 28%, including pneumonia in 5%. The company said the safety profile, including atrial fibrillation/flutter rates, was consistent with prior trials.

The release also notes ongoing Phase 3 CLL/SLL studies: BRUIN CLL-314 (vs ibrutinib), BRUIN CLL-321 (vs IdelaR or BR in covalent BTK-pretreated R/R disease), and BRUIN CLL-322 (pirtobrutinib plus venetoclax/rituximab vs venetoclax/rituximab).