Astellas Pharma’s Vyloy (zolbetuximab-clzb) has been approved by the US Food and Drug Administration (FDA) as part of a first-line combination treatment for a subset of gastric cancer patients.
The claudin 18.2-directed cytolytic 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-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin 18.2 positive.
About 26,890 new cases of gastric cancer are expected to be diagnosed in the US this year and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases.
The disease usually develops slowly over many years and early-stage symptoms frequently overlap with more common stomach-related conditions, causing most cases to go undetected until an advanced or metastatic stage.
Vyloy now is the first and only claudin 18.2-targeted therapy to be approved in the US and was recently approved by the European Commission and UK Medicines and Healthcare products Regulatory Agency for the same patient population.
Among the data supporting the FDA’s decision was results from the late-stage SPOTLIGHT trial, which assessed Vyloy plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6.
Median progression-free survival was 10.61 months with the Vyloy regimen compared to 8.67 months for placebo plus mFOLFOX6, while median overall survival was 18.23 months versus 15.54 months in the respective treatment groups.
The approval was also informed by positive results from the phase 3 GLOW study, which evaluated Vyloy alongside CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin).
Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, said: “The approval of Vyloy as the first and only targeted therapy for CLDN18.2-positive patients in the US further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage.”
Vyloy has also been approved in Japan and South Korea, and Astellas has submitted applications for the drug to regulatory agencies around the world.