TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.
The positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines in all 27 European Union member states as well as Iceland, Liechtenstein, and Norway.
Astellas said it has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.
In addition to the EMA, Astellas has submitted applications to other regulatory agencies around the world with reviews of zolbetuximab ongoing. Zolbetuximab was approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in March 2024, the first and only CLDN18.2-targeted treatment approved by any regulatory agency in the world.
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