“FDA” approves a new drug for the treatment of stomach and esophageal cancer in advanced stages

It has been approved by the US Food and Drug Administration (FDA) On the use of zolbetuximab with platinum-containing chemotherapy for first-line treatment Stomach cancer Or the gastroesophageal junction, according to the Reuters website.

Zolbetuximab was also approved in Japan, Europe and the United Kingdom earlier this year, and the company estimates that the global market will receive around 82,000 patients each year..

According to the US Food and Drug Administration website“FDA”Although progress has been made in treating unresectable advanced cancers of the stomach and small intestine, there is still a need among patients to find more advanced treatments..

Dr. Samuel J. Klempner of Harvard Medical School and Massachusetts General Hospital in Boston said in a company press release that the approval of zolpituximab is a new treatment for patients whose tumors are positive for the protein. CLDN18.2And for those on the front line making treatment decisions.

He said claudin 18.2, which is linked to tumor growth and development, is too high in about 40% of patients. Stomach tumors And the gastroesophageal junction..

Approval was based on the US Food and Drug Administration“FDA” On two international phase III trials — SPIRITUAL LAWS and GLASSIn the Spotlight search SPIRITUAL LAWS performed on 565 patients, add zolbetuximab to chemotherapy with the drug mFOLFOX6 To a significant improvement in median kidney survival and disease progression.

The incidence of adverse effects was similar between the zolbetuximab and placebo groups in both trials..

The recommended dose of zolpituximab in combination with fluoropyrimidine and platinum-containing chemotherapy is 800 mg/m2 intravenously for the first dose, 600 mg/m2 intravenously every 3 weeks, or 400 mg/m2 intravenously every 2 weeks for subsequent doses..