US FDA declines to approve Astellas' gastric cancer drug
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[January 09, 2024]
(Reuters) - Japan's Astellas Pharma said on Monday the U.S. Food
and Drug Administration (FDA) has declined to approve its experimental
drug to treat a type of gastric cancer, citing issues related to a
third-party manufacturer.
The FDA has not raised any concerns related to the clinical data, and is
not requesting additional clinical studies, Astellas 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 antibody-based drug, zolbetuximab, is being developed to treat
patients with a type of locally advanced unresectable gastric or
gastroesophageal junction (GEJ) adenocarcinoma.
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Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File Photo
(Reporting by Mariam Sunny in
Bengaluru; Editing by Rashmi Aich)
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