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FDA grants priority review


Credit © Terese Winslow, National Cancer Institute

CANCER DIGEST – Aug. 26, 2023 – The US FDA has granted priority review status to a new targeted therapy for stomach cancers with a specific genetic mutation.


The agency set January 12, 2024 as the target date for a decision on the drug that could change treatment for patients with previously untreated gastric or esophageal junction cancer that over expresses the protein claudin-18 isoform2 (CLDN18.2).


Gastric cancer is the fifth most diagnosed cancer worldwide, and it has been increasing over the last decade. Patients with stomach cancer or cancer at the junction of the esophagus and the top of the stomach typically have few symptoms. Consequently, diagnosis often comes with advanced disease, when it is difficult to treat. The National Cancer Institute estimates the five-year survival rate at about 7 percent.


The FDA’s priority review follows a large international phase 3 clinical study led by Cornell Medical Center in New York that showed patients treated with the new immunotherapy drug zolbetuximab in combination with a chemotherapy cocktail using capecitabine and oxliplatin, called CAPOX, reduced the risk of disease progression or death by 31 percent compared to the standard CAPOX therapy.


The GLOW study involved 507 patients and was conducted from November 2018 and February 2022 at 166 cancer centers in 18 countries.


Half of those receiving the zolbetuximab survived without their cancer progressing for more than 8.2 months compared to 6.8 months for those on standard chemotherapy, and increased survival to 14.4 months compared to 12.2 months for the standard chemotherapy group. Long-term survival also increased significantly from 17 percent of the CAPOX alone group surviving 2 years compared 29 percent of the zolbetuximab group surviving that long.


The results were published in the July 31, 2023 journal Nature Medicine. If approved, zolbetuximab will be the first targeted therapy in the US for patients with previously untreated advanced gastric or esophageal junction cancer.


Source: Weill Cornell Medicine press release

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