The FDA has approved Vyloy for the treatment of gastric cancer in combination wiht chemotherapy.
The therapy, chemically known as zolbetuximab, is a monoclonal antibody which can attach itself to certain cancer cells and destroy them. When studied in combination with other chemotherapies in late-stage trials, it improved survival in patients compared to placebo.
The treatment 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 manufacturer said the FDA had approved its companion diagnostic test to identify patients who may be eligible for Vyloy. The FDA previously declined to approve the therapy, citing issues related to a third-party manufacturer.
Other approved drugs for patients with advanced gastric or gastroesophageal cancer include AstraZeneca and Daiichi Sankyo's Enhertu and Merck's Keytruda.
Gastric cancer accounts for about 1.5% of all new cancers diagnosed in the U.S. each year, according to the American Cancer Society.