EMA adopts positive opinion for Keytruda in melanoma following complete resection

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A committee of the European Medicines Agency recommended the approval for expanded use of Keytruda (pembrolizumab) as a standalone therapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma who have undergone complete resection.

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Moderna and Merck announced median five-year follow-up data from the phase IIb KEYNOTE-942/mRNA-4157-P201 study, evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with high-risk melanoma (stage 3/4) following complete resection. 

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