Jaypirca (pirtobrutinib) has accelerated approval from the FDA for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two lines of therapy. - Eli Lilly.
Eli Lilly and Company announced that the FDA approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/II BRUIN trial. Continued approval for this indication may be contingent upon verification 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 can extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and a BCL-2 inhibitor. Jaypirca utilizes a novel binding mechanism and has the largest body of evidence of any targeted therapy in patients previously treated with a BTK inhibitor.
"Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients," said William G. Wierda, M.D., Ph.D., professor, medical director, and CLL section head for the Department of Leukemia at The University of Texas MD Anderson Cancer Center. "Jaypirca offers a new treatment option and different approach to targeting BTK, providing clinical benefit for a high proportion of patients with CLL or SLL in the BRUIN Phase 1/II trial whose disease progressed following treatment with a covalent BTK inhibitor and with a BCL-2 inhibitor."
This is the second FDA-approved indication for Jaypirca following the January 2023 Accelerated Approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
Related news and insights
RAPT Therapeutics, Inc. announced that the FDA has verbally notified the company that a clinical hold has been placed on the company’s Phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and its Phase IIa trial in asthma
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC)
Tenax Therapeutics, Inc., a Phase III, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced it has secured global development, commercial, and IP rights to oral and subcutaneous levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)