Early approval denied for Keytruda in breast cancer

10 February 2021

A key scientific panel of the US medicines regulator has voted unanimously to wait for more data before deciding on a bid to broaden the label for Keytruda (pembrolizumab).

In a rare rebuff for the checkpoint blocker, which brought in over $14 billion in revenues for 2020, the panel said it wanted to see more data from the Phase III KEYNOTE-522 trial.

The decision was widely expected, after briefing notes posted to the Food and Drug Administration website ahead of the advisory panel meeting suggested that the design of the study, and the results, do not currently support approval.

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