Friday, February 10, 2023
Jaypirca (pirtobrutinib) has been approved by the U.S. Food and Drug Administration for adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The approval follows after at least two lines of systemic therapy, including a BTK inhibitor, was announced by Loxo@Lilly, the oncology division of Eli Lilly and Company.
The first and only non-covalent (reversible) BTK inhibitor to receive FDA approval is Jaypirca. It extends the benefit of addressing this pathway by re-establishing BTK inhibition in MCL patients who had previously received treatment with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).
Warnings for infections, bleeding, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity are included in the labeling for Jaypirca.
Data from a sample of patients in the BRUIN Phase 1/2 trial served as the basis for the FDA's clearance. The effectiveness evaluation was based on 120 MCL patients who received Jaypirca 200 mg once daily until the disease progressed or the toxicity became intolerable. Jaypirca received FDA approval under the accelerated approval process. Patients are now enrolled in the confirmatory Phase III trial (NCT04662255; BRUIN MCL-321).
Within the next several weeks, Jaypirca is anticipated to become accessible in the US.