FDA Decisions: Astellas Hit with CRL for Claudin 18.2-Targeted Hopeful

 Astellas has failed to gain approval for what would be the first approved therapy targeting claudin 18.2 (CLDN18.2), a transmembrane protein expressed on the surface of gastric epithelial cancer cells. “Unresolved deficiencies” at a third party manufacturing facility are what tripped Astellas up in its bid for approval of zolbetuximab, according to the company’s announcement of the Jan. 4 Complete Response Letter.

Zolbetuximab is being proposed to treat patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.

https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/