Astellas Pharma’s Vyloy (zolbetuximab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as part of a first-line combination treatment for a subset of gastric cancer patients.
The monoclonal antibody has been authorised for use alongside fluoropyrimidine- and platinum-containing chemotherapy to treat adults 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 18.2 positive.
Approximately 6,600 people are diagnosed with gastric cancer in the UK every year and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases.
The disease tends to develop slowly over many years and rarely causes early symptoms, causing most cases to go undetected until an advanced stage.
Vyloy, administered intravenously every two to three weeks, is now the only licensed treatment to target the claudin 18.2 protein, which is expressed in gastric, oesophageal, lung and ovarian tissues.
Timir Patel, medical director at Astellas, said the drug “marks a new era in the targeted treatment of gastric cancer, where more treatment options are desperately needed”.
Among the data supporting the MHRA’s decision was results from the phase 3 SPOTLIGHT trial, which evaluated first-line Vyloy plus mFOLFOX6 – a combination regimen that includes oxaliplatin, leucovorin and fluorouracil – versus placebo plus mFOLFOX6 in patients with claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
The Vyloy regimen was associated with a significant reduction in the risk of disease progression or death compared with placebo, reducing the risk by 24.9%.
The regulator also based its approval on positive results from the late-stage GLOW study, which assessed the drug alongside CAPOX – a combination chemotherapy regimen that includes capecitabine and oxaliplatin – in the same patient population.
The combination reduced the risk of progression or death by 31.3% compared to placebo plus CAPOX, meeting GLOW’s primary endpoint.
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.”
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