ALPMF - FDA denies approval of Astellas gastric cancer drug

2024-01-09 05:49:53 ET

Japanese drugmaker Astellas Pharma ( OTCPK:ALPMY ) said on Monday that the U.S. Food and Drug Administration (FDA) has declined to approve the biologics license application of its experimental gastric cancer drug due to issues related to a third-party manufacturer.

zolbetuximab is being developed to treat patients with a type of locally advanced unresectable gastric or gastroesophageal junction adenocarcinoma. Besides the U.S., regulatory applications are also under review in several other countries and regions, including Japan, Europe, and China.

In a statement, the FDA said that it cannot approve the application by the target date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for the drug.

The agency has not raised any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and is not requesting additional clinical studies, Astellas ( OTCPK:ALPMY ) said.

The company said it is working closely with the FDA and the third-party manufacturer to quickly resolve the regulator's feedback, adding that the decision does not affect any other Astellas product. The impact of this matter on Astellas' ( OTCPK:ALPMY ) financial results in the fiscal year ending March 31, 2024, will be limited.

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