Merck: EC approves new indication for Keytruda

(CercleFinance.com) - Today Merck announced that the European Commission (EC) has approved Keytruda as a single agent for the adjuvant treatment of patients aged 12 years and older with completely resected stage IIB or IIC melanoma.


In addition, the EC also approved an expanded indication for Keytruda in advanced (unresectable or metastatic) and stage III melanoma (as adjuvant treatment after complete resection) from the age of 12 years.

This approval was based on results from a Phase III trial showing that Keytruda significantly prolonged recurrence-free survival (RFS), and reduced the risk of disease recurrence or death by 39% compared to placebo in this patient population, with a median follow-up of 20.5 months.

This approval enables KEYTRUDA to be marketed for this indication in the 27 European Union (EU) Member States plus Iceland, Liechtenstein, Norway and Northern Ireland.


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