FDA Approval: Eli Lilly's Jaypirca for CLL/SLL After Prior Therapies

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least two front lines of therapy including a Brutonand tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Jaypirca was approved through the FDA's accelerated approval pathway based on overall response (ORR) and duration of response (DOR) in the open-label, single-arm, multi-cohort, international phase 1/2 BRUIN study. Continued approval for this indication may require confirmation and description of clinical benefit in a confirmatory trial.

Jaypirca, the first and only FDA-approved non-covalent (reversible) BTK inhibitor, is a highly selective kinase inhibitor that may extend the benefits of targeting the BTK pathway in CLL/SLL patients previously treated with covalent BTK inhibitors (ibrutinib , acalabrutinib). Or zanubrutinib) and a BCL-2 inhibitor.

Jaypirca uses a novel binding mechanism and has the most evidence for targeted therapy in patients previously treated with BTK inhibitors. When patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapy, treatment is limited and outcomes can be poor, making the approval of Jaypirca an important advance for these patients and a much-needed new treatment option. Said William

G. Wierda, M.D., Ph.D., professor, medical director and chief of the CLL Division of the Leukemia Division at The University of Texas MD Anderson Cancer Center. Jaypirca offers a new treatment option and a different approach to targeting BTK, providing clinical benefit to a large proportion of patients with CLL or SLL in the BRUIN Phase 1/2 trial who progressed on a covalent BTK inhibitor and a BCL-2 inhibitor.