US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the United States and Canada, announced on Friday that the European Commission has approved its anti-PD-1 therapy KEYTRUDA (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.
The Commission also approved expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.
This decision was based on positive results from a Phase 3 trial.
KEYTRUDA was already approved in the EU for the treatment of adult patients with advanced (unresectable or metastatic) melanoma and for the adjuvant treatment of adult patients with stage III melanoma and lymph node involvement who have undergone complete resection.
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