First biomarker-driven approval exemplifies cancer immunotherapy progress

A Merck & Co drug has gained the first approval to treat cancer according to its genetic character, rather than type and location in patients’ bodies. This latest marketing go-ahead from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) underlines the growing importance of a cancer’s genetic details for targeted treatments. ‘It does change in a major way how we think about getting drugs approved,’ says Roy Baynes, senior vice president, Global Clinical Development at Merck in Rahway, US.