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Astellas' US Approval for Zolbetuximab Thwarted in Gastric Cancer Due to Manufacturing Deficiencies

NEW YORK – Astellas Pharma this week said it did not receive US Food and Drug Administration approval to market the IgG1 monoclonal antibody zolbetuximab as a treatment for advanced HER2-negative, claudin (CLDN) 18.2-positive gastric cancer.

The FDA was initially slated to issue a decision on Astellas' biologics license application for zolbetuximab in this indication by Jan. 12. However, on Jan. 4, the agency sent Astellas a complete response letter stating that it would not approve the BLA due to deficiencies at the third-party manufacturing facility that produces zolbetuximab.

According to Astellas, the FDA does not have any concerns about zolbetuximab's efficacy or safety or the clinical data it submitted within its BLA. The agency also is not requesting that Astellas conduct any additional research on the agent, according to the firm. As for the unresolved manufacturing deficiencies, Astellas said it is "working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve [the issues raised in] the agency's feedback."

The Tokyo-headquartered firm projected a limited financial impact from the complete response letter.

Astellas is also seeking approval in China, Europe, and Japan for zolbetuximab in HER2-negative, CLDN18.2-positive advanced gastric cancer.