Astellas Pharma has announced that the Scottish Medicines Consortium has accepted zolbetuximab for use on the NHS in Scotland, marking the first national reimbursement recommendation in the UK for a therapy targeting CLDN18.2 in advanced gastric and gastro‑oesophageal junction cancer.
The treatment, used alongside fluoropyrimidine‑ and platinum‑based chemotherapy, is intended for adults with locally advanced unresectable or metastatic HER2‑negative gastric or gastro‑oesophageal junction adenocarcinoma whose tumours test positive for CLDN18.2. Around 38% of such patients are estimated to express this biomarker.
Gastric cancer remains a significant challenge in Scotland, with an estimated 386 people each year diagnosed with advanced or metastatic disease that cannot be removed surgically or has spread elsewhere. Only one in five UK patients with stage 4 stomach cancer survive for a year or more after diagnosis, highlighting the need for new treatment options that slow disease progression and extend life.
Zolbetuximab is described as the first precision medicine designed to bind to CLDN18.2, a protein that helps maintain the integrity of the stomach lining. When cancer develops, this protein can become exposed, enabling the drug to attach to tumour cells and support the immune system in destroying them.
Professor Russell Petty said: “The SMC recommendation of zolbetuximab reflects our ambition as doctors to deliver cutting-edge care for cancer patients in NHS Scotland through precision medicine. By moving beyond one-size-fits-all methods and targeting specific features of a tumour, like CLDN18.2, it’s possible to deliver more effective therapies, ultimately extending a patients’ time with their loved ones.”
Dr Timir Patel explained: “Zolbetuximab is an innovative approach to treating advanced gastric cancer. Today’s recommendation by the SMC highlights the importance of personalised approaches in cancer care and underscores the potential of zolbetuximab to improve patient outcomes.”
He added: “Astellas is dedicated to advancing our understanding of cancer biology to develop treatments for the most challenging cancers. We strive to provide doctors with essential options and patients with more time with their loved ones. Today’s decision shows our commitment to helping patients access treatments in the areas of greatest unmet clinical need.”
The SMC decision draws on data from the phase 3 SPOTLIGHT and GLOW trials, which together enrolled 1072 patients. Both studies showed improvements in progression‑free and overall survival when zolbetuximab was added to standard chemotherapy, with safety profiles comparable to control groups.
