loncastuximab tesirine (Zynlonta)

following a full submission assessed under the end of life and orphan equivalent medicine process:

loncastuximab tesirine (Zynlonta®) is accepted for restricted use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

SMC restriction: where chimeric antigen receptor (CAR) T-cell therapy is unsuitable, not tolerated or ineffective.

In an open-label, single-arm, phase II study, in adults with relapsed or refractory DLBCL (which included HGBL) following two or more multi-agent systemic treatment regimens, loncastuximab tesirine was associated with an overall response rate of 48%.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.