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GSK says EMA validates marketing authorization application for Jemperli

GSK plc announced that the European Medicines Agency has validated the company’s Type II Variation for a potential new indication for Jemperli in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer. As a result, the EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission regarding marketing authorization for the potential new indication.

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Published first on TheFly

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