Loncastuximab tesirine receives EC approval for the treatment of adult patients with R/R DLBCL

On December 21, 2022, it was announced that loncastuximab tesirine, a CD19-targeted antibody–drug conjugate, received approval from the European Commission (EC) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); it marks a major clinical development for patients across Europe with DLBCL.¹

This approval is based on key results from the phase II LOTIS-2 trial (NCT03589469), in which loncastuximab tesirine demonstrated durable responses in heavily pretreated patients with R/R DLBCL following ≥2 prior lines of systemic therapy.

Moreover, this follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in September. Prior to this, the U.S. Food and Drug Administration (FDA) granted its approval for this patient subset in April 2021.