Posted by Michael Wonder on 23 Apr 2021
FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
23 April 2021 - Today the FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.
Approval was based on LOTIS-2, an open-label, single-arm trial in 145 adult patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma after at least two prior systemic regimens.
