(Reuters) -The U.S. Food and Drug Administration approved Astellas’ 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)
Comments