Eli Lilly announced the Jaypirca Approval on October 2, 2026, as the FDA cleared pirtobrutinib for adults with previously untreated CLL/SLL and no known 17p deletion.
Eli Lilly and Company announced results from its Phase 3 BRUIN CLL-322 trial, demonstrating that adding Jaypirca to a venetoclax time-limited regimen cuts the risk of disease progression or death by 45% in previously treated CLL/SLL patients.
Topline results from the Phase 3 BRUIN CLL-322 trial confirm that Jaypirca significantly extended progression-free survival when added to a venetoclax regimen.
Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.
U.S. FDA has granted full approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This expanded indication allows the use of the non-covalent BTK inhibitor immediately following prior covalent BTK inhibitor therapy. The decision is bolstered by data from the Phase 3 BRUIN CLL-321 trial, which demonstrated a statistically significant improvement in progression-free survival compared to standard combinatorial therapies.
Eli Lilly and Company is set to present “striking” new data at the 2025 ASH Annual Meeting, revealing a double victory for its BTK inhibitor, Jaypirca (pirtobrutinib). Results from two pivotal Phase 3 trials demonstrate that Jaypirca not only outperforms standard chemoimmunotherapy in first-line treatment but also meets non-inferiority benchmarks against the established drug ibrutinib. These findings could pave the way for Jaypirca to become a new standard of care for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) across multiple treatment settings.
The European Commission is currently taking final action on the application for the use of Jaypirca in patients with relapsed or refractory CLL who have received prior treatment with a BTK inhibitor as a result of this favorable view.
