Posted by Michael Wonder on 27 Jan 2023
FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma
27 January 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor.
Efficacy was evaluated in BRUIN, an open-label, multi-centre, single-arm trial of pirtobrutinib monotherapy that included 120 patients with mantle cell lymphoma previously treated with a BTK inhibitor.
