Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes after the company addressed third-party manufacturing issues, as the drug’s efficacy and safety were not in question.
The FDA filing is supported by positive Phase III clinical trial results, which demonstrated significant improvements in progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and duration of response (DOR) compared to placebo.
According to the public data, Vyloy received regulatory approval in Japan, marking it as the first CLDN18.2-targeted drug to be approved globally.- Flcube.com
