FDA approves Astellas' gastric cancer therapy (updated)

Astellas Pharma

18/10/2024 17:45

(Adds approval details in paragraphs 2, background in
paragraphs 4-6)
       Oct 18 (Reuters) - The U.S. Food and Drug Administration
approved Astellas'  4503.T  therapy to treat a type of gastric
cancer, the health regulator's website showed on Friday.
        The therapy, branded as Vyloy, was approved to be used
in combination with a type of chemotherapy for patients with a
type of cancer which begins in the gastroesophageal junction,
where the esophagus and stomach meet.
  
        Astellas did not immediately respond to a Reuters
request for pricing and availability details.
  
        It was approved in Japan in March and became the first
targeted therapy to be approved in the world for a type of
family of proteins that binds to cancerous cells commonly seen
in gastric cancers.
  
        Britain's health regulator in August 
    approved
     the therapy to be used in patients whose gastric or
gastro-oesophageal junction cancer cannot be removed by surgery,
or has spread to other parts of the body.
  
        The FDA had previously declined to approve the therapy, 
    citing
     issues related to a third-party manufacturer.
  

 (Reporting by Sriparna Roy in Bengaluru; Editing by Maju
Samuel)
 ((Sriparna.Roy@thomsonreuters.com;))