Medicines Healthcare Products Regulatory Agency
A new targeted cancer treatment, given in combination with a standard chemotherapy, for adults with stomach (gastric) or gastro-oesophageal junction cancer has today 14 August 2024, been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The gastro-oesophageal junction is the place where the gullet (oesophagus) joins the stomach.
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them.
Zolbetuximab is prescribed for patients whose tumours are positive for the Claudin18.2 (CLDN18.2), and negative for the Human epidermal growth factor receptor 2 (HER2) proteins. It is given to patients whose gastric or gastro-oesophageal junction cancer cannot be removed by surgery or has spread to other parts of the body.
Zolbetuximab is prescribed as a combination treatment with other anti-cancer medicines. It is given intravenously (by a drip into a vein) over at least 2 hours in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
The patients doctor will decide how much of this medicine the patient will receive. The patient will usually receive zolbetuximab every 2 or 3 weeks based on the other anti-cancer medicines chosen by their doctor. The patients doctor will decide how many treatments are needed.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access said, This new targeted medicine can extend survival for adults with this type of cancer.
MHRA is assured that the appropriate regulatory standards of quality, efficacy and safety for the approval of this new medicine have been met.
As with all products, we will keep its safety under close review.
Zolbetuximab has been studied in two main Phase 3 clinical trials SPOTLIGHT and GLOW. The SPOTLGHT study investigated the efficacy and safety of first-line zolbetuximab plus mFOLFOX6 (modified folinic acid [or levofolinate], fluorouracil, and oxaliplatin regimen) versus placebo (a dummy treatment) plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, stomach or gastro-oesophageal junction cancer that could not be removed by surgery or had spread to other parts of the body.
The study included 283 patients in the zolbetuximab group and 282 patients in the placebo group. The results showed an improved overall survival for those exposed to zolbetuximab versus placebo. Overall survival was 67.7%, 50.5% and 38.8% at 12, 18 and 24 and months respectively, for the zolbetuximab group. Overall survival in the placebo group was 60.0%, 38.1% and 28.4% at 12, 18 and 24 and months respectively.
The GLOW study investigated the efficacy and safety of first-line zolbetuximab plus CAPOX (capecitabine and oxaliplatin) versus placebo (a dummy treatment) plus CAPOX in patients with CLDN18.2-positive, HER2-negative, stomach or gastro-oesophageal junction cancer that could not be removed by surgery or had spread to other parts of the body.
The study included 254 patients in the zolbetuximab group and 253 patients in the placebo group. The results showed an improved overall survival for those exposed to zolbetuximab versus placebo. Overall survival was 57.5%, 38.1% and 28.9% at 12, 18 and 24 and months respectively, for the zolbetuximab group. Overall survival in the placebo group was 50.8%, 28.1% and 17.4% at 12, 18 and 24 and months respectively.
Zolbetuximab increased median overall survival for adults with stomach (gastric) or gastro-oesophageal junction cancer by about 4 months compared to those administered placebo.
The most common serious side effect with zolbetuximab are nausea and vomiting (which may affect more than 1 in 10 people). Other serious side effects (which may affect up to 1 in 10 people) are hypersensitivity (allergic) reactions (including hypersensitivity and anaphylactic reaction) and infusion related reactions.
The most common other side effects (which may affect more than 1 in 10 people) are decreased appetite; low levels of albumin in the blood (hypoalbuminaemia); and swelling of the lower legs or hands (oedema peripheral).
As with any medicine, the MHRA keeps the safety and effectiveness of zolbetuximab under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website or by searching the Google Play or Apple App stores for MHRA Yellow Card.
ENDS
Notes to editors?
- The new marketing authorisation (licence) was granted on 14 August 2024 to Astellas Pharma Limited.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- Zolbetuximab has been approved as a GB orphan medicine. Orphan medicines are intended for use against rare conditions that are life-threatening or chronically debilitating. To qualify as an orphan medicine, certain criteria, for example concerning the rarity of the disease and the lack of currently available treatments, must be fulfilled.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.?
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal