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Merck: positive opinion from CHMP in adenocarcinoma (GEJ)

(CercleFinance.com) - Merck today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, as first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.


The CHMP recommendation will now be considered by the European Commission for marketing authorisation in the European Union. A final decision is expected soon - in Q4 2023.


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