The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted by Astellas (TYO: 4503), a Japanese pharmaceutical company, for its first-in-class anti-CLDN18.2 biologic zolbetuximab. The drug was under consideration for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Astellas reported that the FDA’s decision stems from deficiencies identified at a third-party manufacturing facility and emphasized that the agency raised no concerns regarding the clinical data and did not request any additional studies.
The company has indicated that it is actively working with both the regulatory authority and the manufacturer to address the issue, and has noted that the financial impact of this rejection is expected to be limited.
As stated in the press release, zolbetuximab has also been submitted for regulatory approval in other significant markets, including China, Europe, and Japan.- Flcube.com
