US regulator approves expanded label for Keytruda

23 March 2021

The US Food and Drug Administration has approved a label update for Merck & Co’s (NYSE: MRK) blockbuster checkpoint blocker, targeting advanced esophageal or gastroesophageal (GEJ) cancer.

Keytruda (pembrolizumab), which took in $14.4 billion sales for the New Jersey, USA-based firm last year, can now be offered for certain people with metastatic or locally advanced GEJ, in combination with chemotherapy.

The decision was made based on data from the KEYNOTE-590 trial, which showed a statistically-significant improvement in overall survival (OS) and progression-free survival (PFS).

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