FDA Approves Astellas' Vyloy for First-Line Gastric Cancer Therapy

Astellas Pharma's Vyloy (zolbetuximab-clzb) has been granted approval by the US Food and Drug Administration (FDA) for use as part of a first-line combination treatment in certain gastric cancer patients. This claudin 18.2-directed cytolytic antibody is to be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma that tests positive for claudin 18.2.

In the US, an estimated 26,890 new cases of gastric cancer are anticipated this year. Adenocarcinomas, which originate from cells in the stomach's innermost lining, constitute the majority of these cases. The disease generally progresses slowly over several years, and early symptoms often resemble those of more common stomach-related ailments, leading to late-stage detection in many patients.

Vyloy stands out as the first and only claudin 18.2-targeted therapy approved in the US. This approval follows recent endorsements by both the European Commission and the UK Medicines and Healthcare products Regulatory Agency for the same patient group.

Key data supporting the FDA’s approval came from the SPOTLIGHT trial, a late-stage study comparing Vyloy plus mFOLFOX6 (a chemotherapy regimen including oxaliplatin, leucovorin, and fluorouracil) to a placebo plus mFOLFOX6. The results demonstrated a median progression-free survival of 10.61 months for the Vyloy regimen, versus 8.67 months for the placebo group. Additionally, median overall survival was 18.23 months with Vyloy, compared to 15.54 months for those receiving the placebo.

The decision was further supported by positive outcomes from the phase 3 GLOW study, which assessed Vyloy in combination with CAPOX, another chemotherapy regimen comprising capecitabine and oxaliplatin.

Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, commented on the significance of Vyloy's approval: “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.”

Besides the US, Vyloy has also secured approvals in Japan and South Korea, and Astellas has submitted regulatory applications for the drug in various other countries globally.