zolbetuximab (Vyloy)

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

zolbetuximab (Vyloy®) is accepted for use within NHSScotland.

Indication under review: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.

In two phase III studies in adult patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumours were positive for CLDN18.2, the addition of zolbetuximab to chemotherapy was associated with statistically significant increases in progression-free survival.

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.