NEW YORK – Astellas said on Thursday that it has filed an application with the US Food and Drug Administration seeking approval for zolbetuximab as a treatment for patients with advanced HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction cancer.
The FDA has accepted the biologics license application (BLA) under priority review and expects to decide whether to approve the drug by Jan. 12, 2024.
Astellas' BLA includes results from the Phase III SPOTLIGHT and GLOW clinical trials, both of which pitted zolbetuximab plus chemotherapy against placebo and chemo in CLDN18.2-positive, HER2-negative gastric and gastroesophageal cancer patients. The studies had similar designs, although the chemotherapy regimens differed, with patients receiving mFOLFOX6 in the SPOTLIGHT trial and CAPOX in the GLOW trial.
To be eligible for these studies, patients had to undergo immunohistochemistry testing and their tumors had to express CLDN18.2 in at least 75 percent of cells. Across the two trials, roughly 38 percent of screened patients with gastric or gastroesophageal junction cancer were CLDN18.2-positive.
If approved, zolbetuximab will be the first gastric cancer therapy that targets CLDN18.2 sold in the US. Last month, Tokyo-based Astellas also submitted an application in Japan seeking approval for zolbetuximab in this same patient population.