Astellas hit by zolbetuximab CRL

Japanese drugmaker Astellas (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for zolbetuximab.

The Tokyo-based firm is seeking approval for the investigational, first-in-class chimeric IgG1 monoclonal antibody for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

"We remain confident in zolbetuximab’s clinical profile"In the CRL, the FDA stated that the agency cannot approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.