FDA approves Jaypirca as first-line treatment for untreated CLL/SLL

The FDA approved Jaypirca (pirtobrutinib) on October 2, 2026 as a first-line treatment for adults with previously untreated CLL or SLL who do not have a 17p deletion. The decision rests on the Phase 3 BRUIN CLL-313 trial, which compared Jaypirca with bendamustine plus rituximab in 282 patients. The approval extends the BTK inhibitor from second-line use into first-line therapy, where it competes with established frontline drugs.

• First-line approval for untreated CLL/SLL without 17p deletion
• BRUIN CLL-313: 282 patients randomized vs bendamustine plus rituximab
• PFS hazard ratio 0.20 (95% CI 0.11-0.37) at 28-month median follow-up
• Overall response rate 94% vs 81%