glofitamab (Columvi)

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

glofitamab (Columvi®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).

SMC restriction: restricted to patients who have progressed during or after one systemic therapy only (that is, for patients in the second line setting).
In a phase III study of patients with relapsed or refractory DLBCL NOS who are ineligible for ASCT, glofitamab in combination with gemcitabine and oxaliplatin significantly improved overall survival compared with rituximab in combination with gemcitabine and oxaliplatin.

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.