The FDA granted accelerated approval to pirtobrutinib (Jaypirca, Lilly) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Efficacy was evaluated in BRUIN, an open-label, multicenter, single-arm trial of pirtobrutinib monotherapy that included 120 patients with MCL previously treated with a BTK inhibitor. Patients had a median of three prior lines of therapy, with 93% having two or more
FEBRUARY 10, 2023